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Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) (BRUIN-MCL-321)

Primary Purpose

Lymphoma, Mantle-Cell

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pirtobrutinib
Ibrutinib
Acalabrutinib
Zanubrutinib
Sponsored by
Loxo Oncology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Mantle-Cell focused on measuring Bruton's Tyrosine Kinase Inhibitor, BTKi, Hematologic Disease, Lymphoma, non-Hodgkin's, Lymphoma, B-Cell, Lymphoma, pirtobrutinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed MCL diagnosis
  • Previously treated with at least one prior line of systemic therapy for MCL
  • Measurable disease per Lugano criteria
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • Absolute neutrophil count ≥ 0.75 × 109/L without granulocyte-colony stimulating factor support within 7 days of screening
  • Hemoglobin ≥ 8 g/dL not requiring transfusion support or growth factors within 7 days of screening
  • Platelets ≥ 50 × 109/L not requiring transfusion support or growth factors within 7 days of screening.
  • AST and ALT ≤ 3.0 x upper limit of normal (ULN).
  • Total bilirubin ≤ 1.5 x ULN.
  • Creatinine clearance of ≥ 30 mL/min according to Cockcroft/Gault Formula

Exclusion Criteria:

  • Prior treatment with an approved or investigational BTK inhibitor
  • History of bleeding diathesis
  • History of stroke or intracranial hemorrhage within 6 months of randomization
  • History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified T-cell (CAR-T) therapy within 60 days of randomization
  • Clinically significant cardiovascular disease
  • Prolonged QT interval corrected using Fridericia's formula (QTcF) > 470 ms on 2/3 consecutive ECGs, and mean QTcF>470 ms on all 3 ECGs
  • Known HIV infection or active HBV, HCV, or CMV infections
  • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption
  • Ongoing chronic treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment.
  • Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
  • Vaccination with live vaccine within 28 days prior to randomization

Sites / Locations

  • Alaska Oncology & Hematology, LLCRecruiting
  • Arizona Oncology Associates, P.C. - HOPERecruiting
  • Arizona Oncology Associates, P.C. - HOPERecruiting
  • St. Joseph Heritage HealthcareRecruiting
  • The Oncology Institute of Hope and InnovationRecruiting
  • UCLA Medical CenterRecruiting
  • Rocky Mountain Cancer CenterRecruiting
  • Medical Oncology Hematology Consultants, PARecruiting
  • Florida Cancer SpecialistsRecruiting
  • Mayo Clinic in FloridaRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Oncology-Hematology Associates of West BrowardRecruiting
  • Florida Cancer Specialists EastRecruiting
  • University of Kentucky Markey Cancer CenterRecruiting
  • Mercy Health-Paducah Medical Oncology and HematologyRecruiting
  • Hematology Oncology ClinicRecruiting
  • Cancer Center Office of Clinical ResearchRecruiting
  • Greenebaum Comprehensive Cancer CenterRecruiting
  • Dana-Farber Cancer InstituteRecruiting
  • University of MichiganRecruiting
  • Karmanos Cancer InstituteRecruiting
  • Mayo ClinicRecruiting
  • Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLCRecruiting
  • Washington University Medical SchoolRecruiting
  • University of Nebraska Medical CenterRecruiting
  • Comprehensive Cancer Centers of NevadaRecruiting
  • Hematology Oncology Associates Of Northern New JerseyRecruiting
  • Columbia University Medical CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • New York Medical CollegeRecruiting
  • Messino Cancer CenterRecruiting
  • Levine Cancer InstituteRecruiting
  • Wake Forest University School of MedicineRecruiting
  • Oncology Hematology Care IncRecruiting
  • Willamette Valley Cancer Institute & Research Ctr.Recruiting
  • Oregon Oncology SpecialistsRecruiting
  • UPMC Hillman Cancer CenterRecruiting
  • Sarah Cannon Research Institute SCRIRecruiting
  • Texas Oncology-Austin MidtownRecruiting
  • Texas Oncology - BedfordRecruiting
  • Texas Oncology - Bayler Charles A. Sammons Cancer CenterRecruiting
  • University of Texas MD Anderson Cancer CenterRecruiting
  • Texas Oncology - McAllenRecruiting
  • Texas Oncology - McKinneyRecruiting
  • Texas Oncology - ShermanRecruiting
  • Texas Oncology - TylerRecruiting
  • Huntsman Cancer InstituteRecruiting
  • University of Virginia Cancer CenterRecruiting
  • Virginia Cancer Specialists, PCRecruiting
  • Seattle Cancer Care AllianceRecruiting
  • University of Wisconsin Carbone Cancer CenterRecruiting
  • Froedtert Memorial Lutheran HospitalRecruiting
  • The St. George HospitalRecruiting
  • Flinders Medical CentreRecruiting
  • Royal Hobart HospitalRecruiting
  • Andrew Lowe Cancer CentreRecruiting
  • Linear Clinical Research LtdRecruiting
  • Royal Perth HospitalRecruiting
  • Icon Cancer Care - The Wesley Medical CentreRecruiting
  • Ordensklinikum Linz GmbH ElisabethinenRecruiting
  • Uniklinikum SalzburgRecruiting
  • Universitair Ziekenhuis GentRecruiting
  • Universitaire Ziekenhuizen Leuven - Campus GasthuisbergRecruiting
  • AZ DeltaRecruiting
  • HC-UFG - Hospital das Clínicas da Universidade Federal de GoiásRecruiting
  • Hospital Sao DomingosRecruiting
  • HMCP - Hospital e Maternidade Celso Pierro - PUC-CampinasRecruiting
  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e OncologiaRecruiting
  • Hospital Sao Lucas CopacabanaRecruiting
  • IEP - Instituto de Ensino e Pesquisas São LucasRecruiting
  • Irmandade da Santa Casa de Misericordia de Sao PauloRecruiting
  • BP A Beneficencia Portuguesa da Sao PauloRecruiting
  • A. C. Camargo Cancer CenterRecruiting
  • HC-FMUSPRecruiting
  • Albert Einstein Sociedade Beneficente Israelita BrasileiraRecruiting
  • Hospital Nove de JulhoRecruiting
  • Cross Cancer InstituteRecruiting
  • BC Cancer VancouverRecruiting
  • CancerCare ManitobaRecruiting
  • Princess Margaret Cancer CentreRecruiting
  • Anhui Provincial Cancer HospitalRecruiting
  • Peking University First HospitalRecruiting
  • Peking University People's HospitalRecruiting
  • Beijing Chaoyang Hospital, Capital Medical UniversityRecruiting
  • Peking University Third HospitalRecruiting
  • Beijing Cancer hospitalRecruiting
  • Fujian Cancer HospitalRecruiting
  • Cancer Center of Guangzhou Medical UniversityRecruiting
  • Sun Yat-sen University Cancer CenterRecruiting
  • Southern Medical University Nanfang HospitalRecruiting
  • The First Affiliated Hospital of Henan Science and Technology UniversityRecruiting
  • Henan Cancer HospitalRecruiting
  • Wuhan Union HospitalRecruiting
  • Yichang Central People's HospitalRecruiting
  • Hunan Cancer HospitalRecruiting
  • The First Affiliated Hospital of Soochow UniversityRecruiting
  • The First Affiliated Hospital of Nanchang UniversityRecruiting
  • Jilin Cancer HospitalRecruiting
  • Shengjing Hospital of China Medical UniversityRecruiting
  • West China Hospital of Sichuan UniversityRecruiting
  • Tianjin Medical University Cancer Institute and HospitalRecruiting
  • Affiliated Tumor Hospital of Xinjiang Medical UniversityRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • Lishui Municipal Central HospitalRecruiting
  • Chongqing Cancer HospitalRecruiting
  • Fudan University Shanghai Cancer CenterRecruiting
  • Blood Institute of the Chinese Academy of Medical scienceRecruiting
  • Fakultni nemocnice BrnoRecruiting
  • Fakultni nemocnice Hradec KraloveRecruiting
  • Aarhus Universitetshospital, Aarhus SygehusRecruiting
  • Odense UniversitetshospitalRecruiting
  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud OuestRecruiting
  • Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie RouenRecruiting
  • CHRU De ToursRecruiting
  • Hopital Saint Vincent De PaulRecruiting
  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-DieuRecruiting
  • Groupe Hospitalier Pitie-SalpetriereRecruiting
  • Centre hospitalier universitaire de Haut LevequeRecruiting
  • Centre Hospitalier Lyon SudRecruiting
  • Pole Regionalde Cancérologie(CHU de Poitiers)Recruiting
  • Chu De Nancy Hop D'Adultes De BraboisRecruiting
  • Institut CurieRecruiting
  • Universitätsklinikum UlmRecruiting
  • Klinikum der Universität München GroßhadernRecruiting
  • Universitaetsklinikum MuensterRecruiting
  • InVO - Institut für Versorgungsforschung in der Onkologie GbRRecruiting
  • Universitaetsklinikum Schleswig-Holstein - Campus KielRecruiting
  • OncoResearch Lerchenfeld GmbHRecruiting
  • Universitätsmedizin Johannes Gutenberg Universität MainzRecruiting
  • Universitaetsklinikum MuensterRecruiting
  • Pecsi Tudomanyegyetem Klinikai KozpontRecruiting
  • Debreceni EgyetemRecruiting
  • St James's HosptialRecruiting
  • Bnai Zion Medical CenterRecruiting
  • Hadassah Medical CenterRecruiting
  • Chaim Sheba Medical CenterRecruiting
  • Tel Aviv Sourasky Medical CenterRecruiting
  • Presidio Ospedaliero Civile Santi Antonio e BiagioRecruiting
  • Azienda Ospedaliero Universitaria Ospedali RiunitiRecruiting
  • Irccs Istituto Tumori Giovanni Paolo IiRecruiting
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei TumoriRecruiting
  • Ospedale San RaffaeleRecruiting
  • Irccs CrobRecruiting
  • IRCCS - AOU di BolognaRecruiting
  • IRCCS Ospedale Policlinico San MartinoRecruiting
  • Azienda Ospedaliera Ospedali Riuniti Papardo PiemonteRecruiting
  • Ospedale Vincenzo CervelloRecruiting
  • Azienda Ospedaliero Universitaria PisanaRecruiting
  • Ospedale Santa Maria delle CrociRecruiting
  • Arcispedale Santa Maria NuovaRecruiting
  • Ospedale di Circolo e Fondazione Macchi VareseRecruiting
  • Nagoya Medical CenterRecruiting
  • Nagoya City University HospitalRecruiting
  • Hokkaido University HospitalRecruiting
  • Kobe City Medical Center General HospitalRecruiting
  • Kochi Medical School HospitalRecruiting
  • Tohoku University HospitalRecruiting
  • Kindai University HospitalRecruiting
  • Saitama Medical CenterRecruiting
  • Japanese Foundation for Cancer ResearchRecruiting
  • NTT Medical Center TokyoRecruiting
  • Chugoku Central HospitalRecruiting
  • Kumamoto University HospitalRecruiting
  • Kyoto Furitsu Medical University HospitalRecruiting
  • Okayama University HospitalRecruiting
  • Gachon University Gil HospitalRecruiting
  • Kosin University Gospel HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • The Catholic University of Korea-Seoul St. Mary's HospitalRecruiting
  • Inje Univ Busan Paik HospitalRecruiting
  • Ziekenhuisapotheek HagaZiekenhuisRecruiting
  • Bravis ZiekenhuisRecruiting
  • Erasmus Medisch CentrumRecruiting
  • Spaarne GasthuisRecruiting
  • Middlemore Clinical TrialsRecruiting
  • Christchurch HospitalRecruiting
  • Centrum Onkologii Ziemi LubelskiejRecruiting
  • Uniwersyteckie Centrum KliniczneRecruiting
  • Pratia MCM KrakowRecruiting
  • Centrum Medyczne Pratia PoznańRecruiting
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WroclawiuRecruiting
  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i TraumatologiiRecruiting
  • IPOFG - LisboaRecruiting
  • Champalimaud FoundationRecruiting
  • Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"Recruiting
  • GUZ of Moscow City Clinical Hospital n.a. S.P. BotkinRecruiting
  • Federal State Budgetary Institution "Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medico-Biological AgencyRecruiting
  • State Medical University named after I.P. PavlovRecruiting
  • Hospital Universitario Virgen de la VictoriaRecruiting
  • Hospital Duran I ReynalsRecruiting
  • Complejo Hospitalario Universitario de SantiagoRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Clinic de BarcelonaRecruiting
  • Hospital General Universitario Gregorio MarañonRecruiting
  • Hospital Infanta LeonorRecruiting
  • Hospital Universitario Fundación Jiménez DíazRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Clinica Universidad de NavarraRecruiting
  • Hospital Universitario Virgen MacarenaRecruiting
  • Hospital Clinico Universitario de ValenciaRecruiting
  • Kantonsspital LuzernRecruiting
  • Ospedale Regionale Bellinzona e ValliRecruiting
  • Tri-Service General HospitalRecruiting
  • Chang Gung Memorial Hospital - ChiayiRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • China Medical University HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Chang Gung Memorial Hospital - LinkouRecruiting
  • Aberdeen Royal InfirmaryRecruiting
  • Churchill HospitalRecruiting
  • Beatson West of Scotland Cancer CentreRecruiting
  • Royal Marsden HospitalRecruiting
  • GenesisCare CambridgeRecruiting
  • City Hospital, Nottingham University HospitalsRecruiting
  • Derriford HospitalRecruiting
  • GenesisCare, WindsorRecruiting
  • New Cross HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A (Pirtobrutinib)

Arm B (Ibrutinib, Acalabrutinib, or Zanubrutinib)

Arm Description

Orally

Investigator's choice (based on local availability) of ibrutinib, acalabrutinib or zanubrutinib orally. Options are limited to those that are available/approved in the specific country.

Outcomes

Primary Outcome Measures

To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL)
Assessed per Lugano criteria

Secondary Outcome Measures

To compare Event Free Survival (EFS) as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Defined as the time from randomization to progressive disease (PD) or start of new treatment for MCL or withdrawal from trial due to toxicity or death
To compare Time to Treatment Failure (TTTF) as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Time from randomization to time when discontinuation criteria met
Time to worsening (TTW) of MCL-related symptoms
Using symptom questions identified from the European Organization for Research and Treatment of Cancer (EORTC) item library. The range of raw scores for these items could be from 0 to 52 with highest score being worse symptoms.
Comparative Tolerability as measured by proportion of time with high side effect burden
Using 18 items covering 10 Patient Reported Outcome- Common Terminology Criteria for Adverse Events (PRO-CTCAE) concepts for frequency (0-5 with 5 as most frequent), and/or presence (0-1 with 1 being present), or Severity (0-5 with 5 as most severe) and/or presence (0-1 with 1 being present); these selective adverse events will be framed and then overall side effect burden will be ascertained with the Functional Assessment of Cancer Therapy (FACT) - Item GP5. The range of this item is 0 -4 with 4 as most bothersome.
To compare Overall Response Rate (ORR) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Assessed per Lugano criteria
To compare Duration of Response (DOR) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Assessed per Lugano criteria
To compare Overall Survival of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Assessed by survival

Full Information

First Posted
December 4, 2020
Last Updated
October 3, 2023
Sponsor
Loxo Oncology, Inc.
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04662255
Brief Title
Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)
Acronym
BRUIN-MCL-321
Official Title
A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loxo Oncology, Inc.
Collaborators
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.
Detailed Description
This is a Phase 3 global, randomized, open-label study comparing pirtobrutinib (Arm A) to investigator's choice of ibrutinib, acalabrutinib or zanubrutinib (Arm B) in MCL patients who have received 1 or more lines of therapy and are BTK inhibitor naïve.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Mantle-Cell
Keywords
Bruton's Tyrosine Kinase Inhibitor, BTKi, Hematologic Disease, Lymphoma, non-Hodgkin's, Lymphoma, B-Cell, Lymphoma, pirtobrutinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (Pirtobrutinib)
Arm Type
Experimental
Arm Description
Orally
Arm Title
Arm B (Ibrutinib, Acalabrutinib, or Zanubrutinib)
Arm Type
Active Comparator
Arm Description
Investigator's choice (based on local availability) of ibrutinib, acalabrutinib or zanubrutinib orally. Options are limited to those that are available/approved in the specific country.
Intervention Type
Drug
Intervention Name(s)
Pirtobrutinib
Other Intervention Name(s)
LOXO-305, LY3527727
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Other Intervention Name(s)
Imbruvica
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Acalabrutinib
Other Intervention Name(s)
Calquence
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Zanubrutinib
Other Intervention Name(s)
Brukinsa
Intervention Description
Oral
Primary Outcome Measure Information:
Title
To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL)
Description
Assessed per Lugano criteria
Time Frame
Up to approximately 24 months
Secondary Outcome Measure Information:
Title
To compare Event Free Survival (EFS) as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Description
Defined as the time from randomization to progressive disease (PD) or start of new treatment for MCL or withdrawal from trial due to toxicity or death
Time Frame
Up to approximately 24 months
Title
To compare Time to Treatment Failure (TTTF) as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Description
Time from randomization to time when discontinuation criteria met
Time Frame
Up to approximately 24 months
Title
Time to worsening (TTW) of MCL-related symptoms
Description
Using symptom questions identified from the European Organization for Research and Treatment of Cancer (EORTC) item library. The range of raw scores for these items could be from 0 to 52 with highest score being worse symptoms.
Time Frame
Up to approximately 24 months
Title
Comparative Tolerability as measured by proportion of time with high side effect burden
Description
Using 18 items covering 10 Patient Reported Outcome- Common Terminology Criteria for Adverse Events (PRO-CTCAE) concepts for frequency (0-5 with 5 as most frequent), and/or presence (0-1 with 1 being present), or Severity (0-5 with 5 as most severe) and/or presence (0-1 with 1 being present); these selective adverse events will be framed and then overall side effect burden will be ascertained with the Functional Assessment of Cancer Therapy (FACT) - Item GP5. The range of this item is 0 -4 with 4 as most bothersome.
Time Frame
Up to approximately 24 months
Title
To compare Overall Response Rate (ORR) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Description
Assessed per Lugano criteria
Time Frame
Up to approximately 24 months
Title
To compare Duration of Response (DOR) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Description
Assessed per Lugano criteria
Time Frame
Up to approximately 24 months
Title
To compare Overall Survival of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
Description
Assessed by survival
Time Frame
Up to approximately 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed MCL diagnosis Previously treated with at least one prior line of systemic therapy for MCL Measurable disease per Lugano criteria Eastern Cooperative Oncology Group (ECOG) 0-2 Absolute neutrophil count ≥ 0.75 × 109/L without granulocyte-colony stimulating factor support within 7 days of screening Hemoglobin ≥ 8 g/dL not requiring transfusion support or growth factors within 7 days of screening Platelets ≥ 50 × 109/L not requiring transfusion support or growth factors within 7 days of screening. AST and ALT ≤ 3.0 x upper limit of normal (ULN) Total bilirubin ≤ 1.5 x ULN. Creatinine clearance of ≥ 30 mL/min according to Cockcroft/Gault Formula Exclusion Criteria: Prior treatment with an approved or investigational BTK inhibitor History of bleeding diathesis History of stroke or intracranial hemorrhage within 6 months of randomization History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified T-cell (CAR-T) therapy within 60 days of randomization Clinically significant cardiovascular disease Prolonged QT interval corrected using Fridericia's formula (QTcF) > 470 ms on 2/3 consecutive ECGs, and mean QTcF>470 ms on all 3 ECGs Known HIV infection or active HBV, HCV, or CMV infections. (Certain participants with controlled HBV infections may still be eligible) Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption Ongoing chronic treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment. Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist. Vaccination with live vaccine within 28 days prior to randomization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patient Advocacy
Phone
1-855-LOXO-305
Email
clinicaltrials@loxooncology.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patient Advocacy
Organizational Affiliation
Loxo Oncology, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Oncology & Hematology, LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
907-257-9851
First Name & Middle Initial & Last Name & Degree
Steven Liu
Facility Name
Arizona Oncology Associates, P.C. - HOPE
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
602-277-4868
First Name & Middle Initial & Last Name & Degree
Michael S Roberts
Facility Name
Arizona Oncology Associates, P.C. - HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
520-886-0206
First Name & Middle Initial & Last Name & Degree
Sudhir Manda
Facility Name
St. Joseph Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
714-446-5804
First Name & Middle Initial & Last Name & Degree
Steven Kim
Facility Name
The Oncology Institute of Hope and Innovation
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
562-693-4477
First Name & Middle Initial & Last Name & Degree
Omkar S Marathe
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
310-582-4070
First Name & Middle Initial & Last Name & Degree
Monica Mead
Facility Name
Rocky Mountain Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
303-385-2000
First Name & Middle Initial & Last Name & Degree
David J Andorsky
Facility Name
Medical Oncology Hematology Consultants, PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
302-366-1200
First Name & Middle Initial & Last Name & Degree
Jamal Misleh
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
239-274-9930
First Name & Middle Initial & Last Name & Degree
Vance M. Wright-Browne
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
904-953-2000
First Name & Middle Initial & Last Name & Degree
Han Tun
Facility Name
Florida Cancer Specialists
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
727-216-1143
First Name & Middle Initial & Last Name & Degree
Gustavo Adolfo Fonseca
Facility Name
Florida Cancer Specialists
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
850-877-8166
First Name & Middle Initial & Last Name & Degree
Viralkumar Bhanderi
Facility Name
Oncology-Hematology Associates of West Broward
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
954-726-0035
First Name & Middle Initial & Last Name & Degree
Sumit Sawhney
Facility Name
Florida Cancer Specialists East
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
561-366-4100
First Name & Middle Initial & Last Name & Degree
Shachar Peles
Facility Name
University of Kentucky Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
859-257-4500
First Name & Middle Initial & Last Name & Degree
Reinhold Munker
Facility Name
Mercy Health-Paducah Medical Oncology and Hematology
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
270-441-4343
First Name & Middle Initial & Last Name & Degree
Wederson M Claudino
Facility Name
Hematology Oncology Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
2257670822260
First Name & Middle Initial & Last Name & Degree
Michael J. Castine
Facility Name
Cancer Center Office of Clinical Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
504-988-6300
First Name & Middle Initial & Last Name & Degree
Nakhle Saba
Facility Name
Greenebaum Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
410-328-7904
First Name & Middle Initial & Last Name & Degree
Seung T Lee
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
617-582-9555
First Name & Middle Initial & Last Name & Degree
Inhye Ahn
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
734-764-1817
First Name & Middle Initial & Last Name & Degree
Tycel J Phillips
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
313-576-9750
First Name & Middle Initial & Last Name & Degree
Dahlia Sano
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
507-284-2511
First Name & Middle Initial & Last Name & Degree
Yucai Wang
Facility Name
Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
816861470057665
First Name & Middle Initial & Last Name & Degree
Suman Kambhampati
Facility Name
Washington University Medical School
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
314-747-7222
First Name & Middle Initial & Last Name & Degree
Brad S. Kahl
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
402-559-5255
First Name & Middle Initial & Last Name & Degree
Julie Vose
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
702-952-3400
First Name & Middle Initial & Last Name & Degree
Edwin Kingsley
Facility Name
Hematology Oncology Associates Of Northern New Jersey
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
973-971-7960
First Name & Middle Initial & Last Name & Degree
Charles M Farber
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
212-305-5098
First Name & Middle Initial & Last Name & Degree
Andrew H Lipsky
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
212-639-2668
First Name & Middle Initial & Last Name & Degree
Anita J Kumar
Facility Name
New York Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10532
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
914-493-7514
First Name & Middle Initial & Last Name & Degree
Delong Liu
Facility Name
Messino Cancer Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
828-212-7021
First Name & Middle Initial & Last Name & Degree
Christopher H Chay
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
980-442-3105
First Name & Middle Initial & Last Name & Degree
Ryan W Jacobs
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
336-716-7972
First Name & Middle Initial & Last Name & Degree
Mary Beth Seegars
Facility Name
Oncology Hematology Care Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
513-686-5270
First Name & Middle Initial & Last Name & Degree
Miguel Islas-Ohlmayer
Facility Name
Willamette Valley Cancer Institute & Research Ctr.
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
5416835001
First Name & Middle Initial & Last Name & Degree
Jeff Porter Sharman
Facility Name
Oregon Oncology Specialists
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
503-561-6444
First Name & Middle Initial & Last Name & Degree
Janelle Meyer
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
412-235-1020
First Name & Middle Initial & Last Name & Degree
Jing-Zhou Hou
Facility Name
Sarah Cannon Research Institute SCRI
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
615-524-4074
First Name & Middle Initial & Last Name & Degree
Ian Flinn
Facility Name
Texas Oncology-Austin Midtown
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
512-421-4100
First Name & Middle Initial & Last Name & Degree
Jason M Melear
Facility Name
Texas Oncology - Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
817-251-9080
First Name & Middle Initial & Last Name & Degree
Henrik Bo Illum
Facility Name
Texas Oncology - Bayler Charles A. Sammons Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
214-370-1763
First Name & Middle Initial & Last Name & Degree
Moshe Levy
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
713-792-2860
First Name & Middle Initial & Last Name & Degree
Luhua Wang
Facility Name
Texas Oncology - McAllen
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
956-687-5150
First Name & Middle Initial & Last Name & Degree
Guillermo Lazo-Diaz
Facility Name
Texas Oncology - McKinney
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
972-867-3577
First Name & Middle Initial & Last Name & Degree
Monte F Jones
Facility Name
Texas Oncology - Sherman
City
Sherman
State/Province
Texas
ZIP/Postal Code
75090
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
903-892-9455
First Name & Middle Initial & Last Name & Degree
Tammy E Roque
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
903-579-9800
First Name & Middle Initial & Last Name & Degree
Habte A Yimer
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
801-585-0255
First Name & Middle Initial & Last Name & Degree
Harsh Shah
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
434-243-2649
First Name & Middle Initial & Last Name & Degree
Craig Anthony Portell
Facility Name
Virginia Cancer Specialists, PC
City
Gainesville
State/Province
Virginia
ZIP/Postal Code
20155
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
703-280-5390
First Name & Middle Initial & Last Name & Degree
Mitul Gandhi
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
206-606-7031
First Name & Middle Initial & Last Name & Degree
Stephen Smith
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
608-287-2304
First Name & Middle Initial & Last Name & Degree
Saurabh Rajguru
Facility Name
Froedtert Memorial Lutheran Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
414-805-4617
First Name & Middle Initial & Last Name & Degree
Nirav Shah
Facility Name
The St. George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
+61291133851
First Name & Middle Initial & Last Name & Degree
Xavier Badoux
Facility Name
Flinders Medical Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
61882045511
First Name & Middle Initial & Last Name & Degree
Bryone Kuss
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
0362228308
First Name & Middle Initial & Last Name & Degree
Anna Johnson
Facility Name
Andrew Lowe Cancer Centre
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
+61352267391
First Name & Middle Initial & Last Name & Degree
Hannah Rose
Facility Name
Linear Clinical Research Ltd
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
WA6009
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
+61893467600
First Name & Middle Initial & Last Name & Degree
Chan Cheah
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
61892242210
First Name & Middle Initial & Last Name & Degree
Peter Thian Guan Tan
Facility Name
Icon Cancer Care - The Wesley Medical Centre
City
Auchenflower
ZIP/Postal Code
4066
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
+61737374500
First Name & Middle Initial & Last Name & Degree
Paul Eliadis
Facility Name
Ordensklinikum Linz GmbH Elisabethinen
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
Phone
43073276760
First Name & Middle Initial & Last Name & Degree
Olga Stiefel
Facility Name
Uniklinikum Salzburg
City
Salzburg
State/Province
Osterreich
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
Phone
+4357255 25801
First Name & Middle Initial & Last Name & Degree
Richard Greil
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Phone
+32 9 332 21 32
First Name & Middle Initial & Last Name & Degree
Fritz Offner
Facility Name
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Phone
3216343821
First Name & Middle Initial & Last Name & Degree
Vibeke Vergote
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Phone
+3251237656
First Name & Middle Initial & Last Name & Degree
Caressa Meert
Facility Name
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
City
Goiânia
State/Province
Goiás
ZIP/Postal Code
74605-020
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
+556239244261
First Name & Middle Initial & Last Name & Degree
Renato Sampaio Tavares
Facility Name
Hospital Sao Domingos
City
São Luís
State/Province
Maranhão
ZIP/Postal Code
65060-645
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
+55 11 96187-9614
First Name & Middle Initial & Last Name & Degree
Gilnara Fontinelle Silva Barros
Facility Name
HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13060-904
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
+551933438450
First Name & Middle Initial & Last Name & Degree
Luciano Fuzzato Silva
Facility Name
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
City
Santo Andre
State/Province
Sao Paulo
ZIP/Postal Code
09060-870
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
+551149935491
First Name & Middle Initial & Last Name & Degree
Debora Bonito
Facility Name
Hospital Sao Lucas Copacabana
City
Rio de Janeiro
ZIP/Postal Code
22061-080
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
+55 21 2545-4348
First Name & Middle Initial & Last Name & Degree
Daniel Goldberg Tabak
Facility Name
IEP - Instituto de Ensino e Pesquisas São Lucas
City
Sao Paulo
ZIP/Postal Code
01236-030
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
+551136606032
First Name & Middle Initial & Last Name & Degree
Marcelo Bellesso
Facility Name
Irmandade da Santa Casa de Misericordia de Sao Paulo
City
São Paulo
ZIP/Postal Code
01221-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
+55 11 97109-8100
First Name & Middle Initial & Last Name & Degree
Sergio Augusto Buzian Brasil
Facility Name
BP A Beneficencia Portuguesa da Sao Paulo
City
São Paulo
ZIP/Postal Code
01323-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
+5511945205782
First Name & Middle Initial & Last Name & Degree
Bruno Sussumu Maeda
Facility Name
A. C. Camargo Cancer Center
City
São Paulo
ZIP/Postal Code
01509-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
+55 11 2189-5000
First Name & Middle Initial & Last Name & Degree
Talita Maira Bueno da Silverira da Rocha
Facility Name
HC-FMUSP
City
São Paulo
ZIP/Postal Code
05403-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
+55 11 4573-7543
First Name & Middle Initial & Last Name & Degree
Juliana Pereira
Facility Name
Albert Einstein Sociedade Beneficente Israelita Brasileira
City
São Paulo
ZIP/Postal Code
05652-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
+55 11 99292-6463
First Name & Middle Initial & Last Name & Degree
Guiherme Fleury Perini
Facility Name
Hospital Nove de Julho
City
São Paulo
ZIP/Postal Code
1409902
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
+551131479982
First Name & Middle Initial & Last Name & Degree
Vinicius De Molla
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
7804071584
First Name & Middle Initial & Last Name & Degree
Anthea Peters
Facility Name
BC Cancer Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
6048776000
First Name & Middle Initial & Last Name & Degree
Alina Gerrie
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
(204) 235-3196
First Name & Middle Initial & Last Name & Degree
Pamela Skrabek
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4X 1K9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
(416) 946-4501
First Name & Middle Initial & Last Name & Degree
Sita Bhella
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8618900518383
First Name & Middle Initial & Last Name & Degree
Kaiyang Ding
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
861066551122
First Name & Middle Initial & Last Name & Degree
Yujun Dong
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
13439999810
First Name & Middle Initial & Last Name & Degree
Yang Shenmiao
Facility Name
Beijing Chaoyang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100141
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8601051718492
First Name & Middle Initial & Last Name & Degree
Zhongxia Huang
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
861062017691
First Name & Middle Initial & Last Name & Degree
Xiaoyan Ke
Facility Name
Beijing Cancer hospital
City
Haidian District
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8613683398726
First Name & Middle Initial & Last Name & Degree
Yuqin Song
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8615860091017
First Name & Middle Initial & Last Name & Degree
Yu Yang
Facility Name
Cancer Center of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8613688896983
First Name & Middle Initial & Last Name & Degree
Chuan Jin
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+862087343535
First Name & Middle Initial & Last Name & Degree
Xiaoxiao Wang
Facility Name
Southern Medical University Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
020 61641888
First Name & Middle Initial & Last Name & Degree
Ru Feng
Facility Name
The First Affiliated Hospital of Henan Science and Technology University
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8615137938070
First Name & Middle Initial & Last Name & Degree
Ling Qin
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
13938239725
First Name & Middle Initial & Last Name & Degree
Kenshu Zhou
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
862785726136
First Name & Middle Initial & Last Name & Degree
Guohui Cui
Facility Name
Yichang Central People's Hospital
City
Yichang
State/Province
Hubei
ZIP/Postal Code
443003
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8618672907182
First Name & Middle Initial & Last Name & Degree
Jingming Guo
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8673188651900
First Name & Middle Initial & Last Name & Degree
Hui Zhou
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215066
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8613862553199
First Name & Middle Initial & Last Name & Degree
Zhengming Jin
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8613970038386
First Name & Middle Initial & Last Name & Degree
Fei Li
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8643185536383
First Name & Middle Initial & Last Name & Degree
Ying Cheng
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
18940251881
First Name & Middle Initial & Last Name & Degree
Wei Yang
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+862885422114
First Name & Middle Initial & Last Name & Degree
Liqun Zou
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+861862223340123
First Name & Middle Initial & Last Name & Degree
Huilai Zhang
Facility Name
Affiliated Tumor Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830002
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8613669926688
First Name & Middle Initial & Last Name & Degree
Shun'e Yang
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8613857182590
First Name & Middle Initial & Last Name & Degree
Haiyan Yang
Facility Name
Lishui Municipal Central Hospital
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323000
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8618368406114
First Name & Middle Initial & Last Name & Degree
Linjie Li
Facility Name
Chongqing Cancer Hospital
City
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8613647633737
First Name & Middle Initial & Last Name & Degree
Ying Xiang
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
13601698395
First Name & Middle Initial & Last Name & Degree
Junning Cao
Facility Name
Blood Institute of the Chinese Academy of Medical science
City
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8615900265415
First Name & Middle Initial & Last Name & Degree
Shuhua Yi
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
Phone
+420532233642
First Name & Middle Initial & Last Name & Degree
Jiri Mayer
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
Phone
+420495832159
First Name & Middle Initial & Last Name & Degree
David Belada
Facility Name
Aarhus Universitetshospital, Aarhus Sygehus
City
Aarhus N
State/Province
Jutland
ZIP/Postal Code
DK-8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
Phone
+4521391053
First Name & Middle Initial & Last Name & Degree
Bentzen Hans Herluf Nørregaard
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
Phone
+4551640958
First Name & Middle Initial & Last Name & Degree
Jacob Haaber Christensen
Facility Name
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
City
Bordeaux
State/Province
Aquitaine
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
33556333244
First Name & Middle Initial & Last Name & Degree
Fontanet Bijou
Facility Name
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
City
Rouen
State/Province
Seine-Maritime
ZIP/Postal Code
76038
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
+33232082223
First Name & Middle Initial & Last Name & Degree
Herve Tilly
Facility Name
CHRU De Tours
City
Tours
State/Province
Tours Cedex 9
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
+33247473712
First Name & Middle Initial & Last Name & Degree
Caroline Dartigeas
Facility Name
Hopital Saint Vincent De Paul
City
Lille cedex
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
+33320874532
First Name & Middle Initial & Last Name & Degree
Amorim Sandy
Facility Name
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
02 40 08 32 71
First Name & Middle Initial & Last Name & Degree
Thomas Gastinne
Facility Name
Groupe Hospitalier Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
+33142162330
First Name & Middle Initial & Last Name & Degree
Veronique Morel-Malek
Facility Name
Centre hospitalier universitaire de Haut Leveque
City
Pessac Cedex
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
+33557656511
First Name & Middle Initial & Last Name & Degree
Kamal Bouabdallah
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
+33478864307
First Name & Middle Initial & Last Name & Degree
Violaine Safar
Facility Name
Pole Regionalde Cancérologie(CHU de Poitiers)
City
Politiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
+33549444472
First Name & Middle Initial & Last Name & Degree
Vincent Delwail
Facility Name
Chu De Nancy Hop D'Adultes De Brabois
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
+33383153257
First Name & Middle Initial & Last Name & Degree
Pierre Feugier
Facility Name
Institut Curie
City
Saint-Cloud
State/Province
Île-de-France
ZIP/Postal Code
92210
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
+33 1 47 11 15 15
First Name & Middle Initial & Last Name & Degree
Carole Soussain
Facility Name
Universitätsklinikum Ulm
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
+4973150056000
First Name & Middle Initial & Last Name & Degree
Stephan Stilgenbauer
Facility Name
Klinikum der Universität München Großhadern
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
+498970950
First Name & Middle Initial & Last Name & Degree
Martin Dreyling
Facility Name
Universitaetsklinikum Muenster
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
+49251-83-44567
First Name & Middle Initial & Last Name & Degree
Andrea Kerkhoff
Facility Name
InVO - Institut für Versorgungsforschung in der Onkologie GbR
City
Koblenz
State/Province
Rhineland-Palatinate
ZIP/Postal Code
65068
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
+49 261 921 5693 20
First Name & Middle Initial & Last Name & Degree
Rudolf Weide
Facility Name
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
City
Kiel
State/Province
Schleswig Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
+4943116974219
First Name & Middle Initial & Last Name & Degree
Christiane Pott
Facility Name
OncoResearch Lerchenfeld GmbH
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
+49402260465052
First Name & Middle Initial & Last Name & Degree
Thomas Wolff
Facility Name
Universitätsmedizin Johannes Gutenberg Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
+496131175040
First Name & Middle Initial & Last Name & Degree
Georg Hess
Facility Name
Universitaetsklinikum Muenster
City
Munster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
+49251-83-44567
First Name & Middle Initial & Last Name & Degree
Andrea Kerkhoff
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7632
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
Phone
'+36305424314
First Name & Middle Initial & Last Name & Degree
Hussain Hussain Alizadeh
Facility Name
Debreceni Egyetem
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
Phone
+3652255196
First Name & Middle Initial & Last Name & Degree
Arpad Illes
Facility Name
St James's Hosptial
City
Dublin
State/Province
Dublin 8
ZIP/Postal Code
D08 NHY1
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
Phone
00353 1410 3546
First Name & Middle Initial & Last Name & Degree
Elisabeth Vandenberghe
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
+972506268114
First Name & Middle Initial & Last Name & Degree
Tamar Tadmor
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
+972508946168
First Name & Middle Initial & Last Name & Degree
David Lavie
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
+97239377906
First Name & Middle Initial & Last Name & Degree
Irena Amitai
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
+97236973782
First Name & Middle Initial & Last Name & Degree
Yair Herishanu
Facility Name
Presidio Ospedaliero Civile Santi Antonio e Biagio
City
Alessandria
State/Province
AL
ZIP/Postal Code
15100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+390131206440
First Name & Middle Initial & Last Name & Degree
Francesco Zallio
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
City
Torrette
State/Province
Ancona
ZIP/Postal Code
60020
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+39715964235
First Name & Middle Initial & Last Name & Degree
Attilio Olivieri
Facility Name
Irccs Istituto Tumori Giovanni Paolo Ii
City
Viale Orazio Flacco
State/Province
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+39805555224
First Name & Middle Initial & Last Name & Degree
ATTILIO GUARINI
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+39543739100
First Name & Middle Initial & Last Name & Degree
Gerardo Musuraca
Facility Name
Ospedale San Raffaele
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+390226437649
First Name & Middle Initial & Last Name & Degree
Andrés Ferreri
Facility Name
Irccs Crob
City
Rionero in Vulture
State/Province
Potenza
ZIP/Postal Code
85028
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+39972726685
First Name & Middle Initial & Last Name & Degree
Giuseppe Pietrantuono
Facility Name
IRCCS - AOU di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+39 051 214 4082
First Name & Middle Initial & Last Name & Degree
Pier Luigi Zinzani
Facility Name
IRCCS Ospedale Policlinico San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+39103358978
First Name & Middle Initial & Last Name & Degree
Roberto Lemoli
Facility Name
Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte
City
Messina
ZIP/Postal Code
98158
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+39903992246
First Name & Middle Initial & Last Name & Degree
Donato Mannina
Facility Name
Ospedale Vincenzo Cervello
City
Palermo
ZIP/Postal Code
90100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+390916884002
First Name & Middle Initial & Last Name & Degree
Caterina Patti
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+3950993488
First Name & Middle Initial & Last Name & Degree
Sara Galimberti
Facility Name
Ospedale Santa Maria delle Croci
City
Ravenna
ZIP/Postal Code
48020
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+390544286223
First Name & Middle Initial & Last Name & Degree
Monica Tani
Facility Name
Arcispedale Santa Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+390522296623
First Name & Middle Initial & Last Name & Degree
Fiorella Ilariucci
Facility Name
Ospedale di Circolo e Fondazione Macchi Varese
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+39332278848
First Name & Middle Initial & Last Name & Degree
Michele Merli
Facility Name
Nagoya Medical Center
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
+81529511111
First Name & Middle Initial & Last Name & Degree
Hirokazu Nagai
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
+81528515511
First Name & Middle Initial & Last Name & Degree
Shigeru Kusumoto
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
+81117161161
First Name & Middle Initial & Last Name & Degree
Daigo Hashimoto
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
+81-78-302-4321
First Name & Middle Initial & Last Name & Degree
Ryusuke Yamamoto
Facility Name
Kochi Medical School Hospital
City
Nankoku
State/Province
Kochi
ZIP/Postal Code
783-8505
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
+81952316511
First Name & Middle Initial & Last Name & Degree
Kensuke Kojima
Facility Name
Tohoku University Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
+81227177165
First Name & Middle Initial & Last Name & Degree
Noriko Fukuhara
Facility Name
Kindai University Hospital
City
Osaka Sayama-shi
State/Province
Osaka
ZIP/Postal Code
589 8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
+81723660221
First Name & Middle Initial & Last Name & Degree
Takahiro Kumode
Facility Name
Saitama Medical Center
City
Kawagoe
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
+81492283400
First Name & Middle Initial & Last Name & Degree
Masahiro Kizaki
Facility Name
Japanese Foundation for Cancer Research
City
Koto
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
+81335200111
First Name & Middle Initial & Last Name & Degree
Dai Maruyama
Facility Name
NTT Medical Center Tokyo
City
Shinagawa-KU
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
+81334486111
First Name & Middle Initial & Last Name & Degree
Kensuke Usuki
Facility Name
Chugoku Central Hospital
City
Hiroshima
ZIP/Postal Code
720-0001
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
+81849702121
First Name & Middle Initial & Last Name & Degree
Taiga Kuroi
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
+81963442111
First Name & Middle Initial & Last Name & Degree
Hiro Tatetsu
Facility Name
Kyoto Furitsu Medical University Hospital
City
Kyoto-shi
ZIP/Postal Code
602 8566
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
+81752515111
First Name & Middle Initial & Last Name & Degree
Junya Kuroda
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
+81862237151
First Name & Middle Initial & Last Name & Degree
Daisuke Ennishi
Facility Name
Gachon University Gil Hospital
City
Namdong-gu
State/Province
Incheon-gwangyeoksi [Incheon]
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
+82324602858
First Name & Middle Initial & Last Name & Degree
JAE-HOON LEE
Facility Name
Kosin University Gospel Hospital
City
Busan
State/Province
Seogu
ZIP/Postal Code
49267
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
+82519905820
First Name & Middle Initial & Last Name & Degree
Ho Sup Lee
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul, Korea
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
+821091175012
First Name & Middle Initial & Last Name & Degree
youngil Koh
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
+82222281972
First Name & Middle Initial & Last Name & Degree
Jin Seok Kim
Facility Name
Asan Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
+82230105940
First Name & Middle Initial & Last Name & Degree
Dok Hyun Yoon
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
+82234106548
First Name & Middle Initial & Last Name & Degree
WON SEOG KIM
Facility Name
The Catholic University of Korea-Seoul St. Mary's Hospital
City
Seocho-Gu
State/Province
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
+82222286056
First Name & Middle Initial & Last Name & Degree
Ki-Seong Eom
Facility Name
Inje Univ Busan Paik Hospital
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
+82-51-890-6407
First Name & Middle Initial & Last Name & Degree
Won Sik Lee
Facility Name
Ziekenhuisapotheek HagaZiekenhuis
City
Den Haag
ZIP/Postal Code
2545 AA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
Phone
+317003592000
First Name & Middle Initial & Last Name & Degree
Lara Bohmer
Facility Name
Bravis Ziekenhuis
City
Roosendaal
ZIP/Postal Code
4708 AE
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
Phone
+31887066820
First Name & Middle Initial & Last Name & Degree
Nicole de Graauw
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 AA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
Phone
+31107041367
First Name & Middle Initial & Last Name & Degree
Jeannette Doorduijn
Facility Name
Spaarne Gasthuis
City
TM Hoofddorp
ZIP/Postal Code
2134
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
Phone
+31238907171
First Name & Middle Initial & Last Name & Degree
Aart Beeker
Facility Name
Middlemore Clinical Trials
City
Papatoetoe
State/Province
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
Phone
+64021955207
First Name & Middle Initial & Last Name & Degree
Rajeeve Rajagopal
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
Phone
+6433640377
First Name & Middle Initial & Last Name & Degree
Peter Ganly
Facility Name
Centrum Onkologii Ziemi Lubelskiej
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-081
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
+48814541226
First Name & Middle Initial & Last Name & Degree
Krzysztof Giannopoulos
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
+48583492230
First Name & Middle Initial & Last Name & Degree
Magdalena Dutka
Facility Name
Pratia MCM Krakow
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
+48602338290
First Name & Middle Initial & Last Name & Degree
Wojciech Jurczak
Facility Name
Centrum Medyczne Pratia Poznań
City
Skórzewo
ZIP/Postal Code
60-185
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48793602210
First Name & Middle Initial & Last Name & Degree
Michał Kwiatek
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
+48785050296
First Name & Middle Initial & Last Name & Degree
Tomasz Wrobel
Facility Name
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii
City
Łódź
ZIP/Postal Code
93510
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
+48602272952
First Name & Middle Initial & Last Name & Degree
Tadeusz Robak
Facility Name
IPOFG - Lisboa
City
Lisboa
ZIP/Postal Code
1099-035
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
Phone
+351217200441
First Name & Middle Initial & Last Name & Degree
Filipa Moita
Facility Name
Champalimaud Foundation
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
Phone
+351210480200
First Name & Middle Initial & Last Name & Degree
Cristina Joao
Facility Name
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
City
Omsk
State/Province
Omskaya Oblast'
ZIP/Postal Code
644013
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
Phone
+79136882778
First Name & Middle Initial & Last Name & Degree
Mikhail V. Dvorkin
Facility Name
GUZ of Moscow City Clinical Hospital n.a. S.P. Botkin
City
Moscow
ZIP/Postal Code
125101
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
Phone
+74997288488
First Name & Middle Initial & Last Name & Degree
Vladimir Vorobyev
Facility Name
Federal State Budgetary Institution "Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medico-Biological Agency
City
Saint Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
Phone
+79213708846
First Name & Middle Initial & Last Name & Degree
Aleksei Kuvshinov
Facility Name
State Medical University named after I.P. Pavlov
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
Phone
+78129096209
First Name & Middle Initial & Last Name & Degree
Natalia Mikhailova
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
951032508
First Name & Middle Initial & Last Name & Degree
ANTONIO Rueda Domínguez
Facility Name
Hospital Duran I Reynals
City
Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
+34932607733
First Name & Middle Initial & Last Name & Degree
Eva González Barca
Facility Name
Complejo Hospitalario Universitario de Santiago
City
A Coruña
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
+3495054993
First Name & Middle Initial & Last Name & Degree
Adrian Mosquera Orgueira
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
+34 932746000
First Name & Middle Initial & Last Name & Degree
Francesc Bosch Albareda
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
+34932275400 Ext 4353
First Name & Middle Initial & Last Name & Degree
Eva Soca
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
+34915868394
First Name & Middle Initial & Last Name & Degree
Mariana Bastos Oreiro
Facility Name
Hospital Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
+34911918932
First Name & Middle Initial & Last Name & Degree
Jose Angel Hernandes Rivas
Facility Name
Hospital Universitario Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
+34915504800-2218
First Name & Middle Initial & Last Name & Degree
Raul Córdoba Mascuñano
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
+34913908678
First Name & Middle Initial & Last Name & Degree
Ana Jimenez Ubieto
Facility Name
Clinica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
+34913908282
First Name & Middle Initial & Last Name & Degree
Carlos Grande Garcia
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
+3495054993
First Name & Middle Initial & Last Name & Degree
Isabel Maria Fernandez Roman
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
+34 619 943 699
First Name & Middle Initial & Last Name & Degree
Alfonso Algarra
Facility Name
Kantonsspital Luzern
City
Luzern 16
State/Province
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
Phone
+41412055876
First Name & Middle Initial & Last Name & Degree
Thilo Zander
Facility Name
Ospedale Regionale Bellinzona e Valli
City
Bellinzona
ZIP/Postal Code
CH-6500
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
Phone
+41918118931
First Name & Middle Initial & Last Name & Degree
Anastasios Stathis
Facility Name
Tri-Service General Hospital
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
+886287923311
Ext
1714
First Name & Middle Initial & Last Name & Degree
Yeu-Chin Chen
Facility Name
Chang Gung Memorial Hospital - Chiayi
City
Chiayi County
ZIP/Postal Code
61363
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
+8865362100 2106
First Name & Middle Initial & Last Name & Degree
Chih-Cheng Chen
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
+88673121101-6110
First Name & Middle Initial & Last Name & Degree
Hui-Hui Hsiao
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
+886422052121
Ext
5050
First Name & Middle Initial & Last Name & Degree
Su-Peng Yeh
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
+886623535354620
First Name & Middle Initial & Last Name & Degree
Tsai-Yun chen
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
+886223133456
Ext
66259
First Name & Middle Initial & Last Name & Degree
Tai-Chung Huang
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
+886228712121
Ext
8904
First Name & Middle Initial & Last Name & Degree
Jyh-Pyng Gau
Facility Name
Chang Gung Memorial Hospital - Linkou
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
+88633281200 2524
First Name & Middle Initial & Last Name & Degree
Hsuan-Jen Shih
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Aberdeen City
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
+443454566000
First Name & Middle Initial & Last Name & Degree
Gavin Preston
Facility Name
Churchill Hospital
City
Headington
State/Province
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
+4407728268414
First Name & Middle Initial & Last Name & Degree
Toby Eyre
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Stratchclyde
ZIP/Postal Code
G12OYN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
+441413017000
First Name & Middle Initial & Last Name & Degree
Pamela McKay
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
+442086613582
First Name & Middle Initial & Last Name & Degree
Ian Chau
Facility Name
GenesisCare Cambridge
City
Newmarket
ZIP/Postal Code
CB8 7XN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
+441223245151
First Name & Middle Initial & Last Name & Degree
George Follows
Facility Name
City Hospital, Nottingham University Hospitals
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
+441159691169
First Name & Middle Initial & Last Name & Degree
Mark Bishton
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
Pl6 8DH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
+441752432595
First Name & Middle Initial & Last Name & Degree
David Lewis
Facility Name
GenesisCare, Windsor
City
Windsor
ZIP/Postal Code
SL4 3HD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
0175341-8444
First Name & Middle Initial & Last Name & Degree
Jaimal Kothari
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
+441902695271
First Name & Middle Initial & Last Name & Degree
Abraham Jacob

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36377973
Citation
Eyre TA, Shah NN, Dreyling M, Jurczak W, Wang Y, Cheah CY, Song Y, Gandhi M, Chay C, Sharman J, Andorsky DJ, Messersmith HM, Ruppert AS, Muthig VA, Ito R, Wang ML. BRUIN MCL-321: phase III study of pirtobrutinib versus investigator choice of BTK inhibitor in BTK inhibitor naive mantle cell lymphoma. Future Oncol. 2022 Nov;18(36):3961-3969. doi: 10.2217/fon-2022-0976. Epub 2022 Nov 15.
Results Reference
derived
PubMed Identifier
36164121
Citation
Ito R, Eyre TA, Shah NN, Gouill SL, Dreyling M, Vandenberghe E, Jurczak W, Wang Y, Cheah CY, Gandhi M, Chay C, Sharman J, Andorsky DJ, Song Y, Stark A, Muthig V, Wang ML. MCL-135 BRUIN MCL-321, a Phase 3 Open-Label, Randomized Study of Pirtobrutinib Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated, BTK Inhibitor Naive Mantle Cell Lymphoma (Trial in Progress). Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S395-S396. doi: 10.1016/S2152-2650(22)01570-1.
Results Reference
derived

Learn more about this trial

Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

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