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Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-321)

Primary Purpose

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LOXO-305
Idelalisib
Bendamustine
Rituximab
Sponsored by
Loxo Oncology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Hematologic Disease, Lymphoma, non-Hodgkin's, Lymphoma, B-cell, Lymphoma, Bruton's tyrosine kinase inhibitor, Ibrutinib, Acalabrutinib, Zanubrutinib, Pirtobrutinib

Eligibility Criteria

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

Inclusion Criteria:

  • Confirmed diagnosis of CLL/SLL requiring therapy as defined by iwCLL 2018 criteria
  • Previously treated with a covalent BTK inhibitor
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • Absolute neutrophil count ≥ 0.75 × 109/L without granulocyte-colony stimulating factor support
  • Hemoglobin ≥ 8 g/dL not requiring transfusion support or growth factors within 14 days of Cycle 1 Day 1
  • Platelets ≥ 50 × 109/L not requiring transfusion support or growth factors within 14 days of C1D1. If an investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be ≥ (75 × 109/L).
  • AST and ALT ≤ 3.0 x upper limit of normal (ULN).
  • Total bilirubin ≤ 1.5 x ULN.
  • Estimated creatinine clearance of ≥ 30 mL/min.

Exclusion Criteria:

  • Known or suspected Richter's transformation at any time preceding enrollment.
  • Known or suspected history of central nervous system (CNS) involvement by CLL/SLL
  • Ongoing drug-induced liver injury
  • Active uncontrolled auto-immune cytopenia
  • Significant cardiovascular disease
  • History of allogeneic or stem cell transplantation (SCT) or chimeric antigen receptor-modified T cells (CAR-T) therapy within the past 60 days
  • Active hepatitis B or hepatitis C
  • Known active cytomegalovirus (CMV) infection.
  • Active uncontrolled systemic bacterial, viral, fungal or parasitic infection.
  • Known Human Immunodeficiency Virus (HIV) infection, regardless of CD4 count.
  • Clinically significant active malabsorption syndrome or inflammatory bowel disease
  • Prior exposure to non-covalent (reversible) BTK inhibitor.
  • Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
  • Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers and/or strong P-glycoprotein (P-gp) inhibitors
  • Vaccination with a live vaccine within 28 days prior to randomization
  • Patients with the following hypersensitivity:

    1. Known hypersensitivity, including anaphylaxis, to any component or excipient of LOXO-305, idelalisib, and bendamustine
    2. Prior significant hypersensitivity to rituximab

Sites / Locations

  • Southern Cancer Center, P.C.
  • Mitchell Cancer Institute -University of South Alabama
  • Palo Verde Hematology Oncology
  • Arizona Oncology Associates, P.C. - HOPE
  • Orange Coast Memorial Medical Center
  • California Research Institute
  • Rocky Mountain Cancer Center
  • Medical Oncology Hematology Consultants, PA
  • Boca Raton Regional Hospital
  • Cancer Specialists of North Florida -St Augustine
  • Oncology-Hematology Associates of West Broward
  • WellStar Health System
  • Rush University Medical Center
  • Illinois Cancer Specialists-Niles
  • Community Health Network
  • Arnett Cancer Center
  • University of Kentucky Markey Cancer Center
  • Norton Cancer Institute
  • Mercy Health-Paducah Medical Oncology and Hematology
  • Cancer Center Office of Clinical Research
  • Greenebaum Comprehensive Cancer Center
  • Saint Joseph Mercy Hospital
  • Ascension St. John Hospital
  • Minnesota Oncology/Hematology PA
  • St. Vincent Frontier Cancer Center
  • Nebraska Hematology-Oncology
  • New Jersey Center for Cancer Research
  • Memorial Sloan Kettering Cancer Center
  • University of Rochester
  • Clinical Research Alliance, Inc.
  • Oncology Hematology Care Inc
  • Willamette Valley Cancer Institute and Research Center
  • Carolina Blood and Cancer Care Associates
  • Texas Oncology - Amarillo
  • Texas Oncology Cancer Center
  • Texas Oncology - Medical City Dallas
  • Texas Oncology - Dallas Presbyterian Hospital
  • Brooke Army Medical Center
  • Texas Oncology Fort Worth
  • The Center for Cancer and Blood Disorders
  • Texas Oncology - McAllen
  • Texas Oncology - San Antonio Medical Center
  • Virginia Cancer Specialists, PC
  • Oncology and Hematology Associates of Southwest Virginia Inc
  • Northwest Medical Specialties, PLLC
  • University of Wisconsin Carbone Cancer Center
  • Canberra Hospital
  • St Vincent's Hospital
  • The St. George Hospital
  • Ingham Institute of Medical Research
  • Westmead Hospital
  • The Alfred Hospital
  • Royal Perth Hospital
  • Ordensklinikum Linz GmbH Elisabethinen
  • Uniklinikum Salzburg
  • Medizinische Universität Wien
  • CHR Verviers-Onco
  • VITAZ
  • AZ Delta
  • Universitair Ziekenhuis Gent
  • Groupe Jolimont
  • AZ St-Elisabeth
  • Clinique Saint Pierre Ottignies
  • Cancer Care Manitoba
  • Queen Elizabeth II Health Sciences Center
  • Southlake Regional Health Centre
  • Princess Margaret Hospital (Ontario)
  • Peking University First HospitalRecruiting
  • Peking University Third HospitalRecruiting
  • Xuanwu Hospital Capital Medical UniversityRecruiting
  • Gansu Province Cancer HospitalRecruiting
  • Sun Yat-sen University Cancer CenterRecruiting
  • Southern Medical University Nanfang HospitalRecruiting
  • Hainan Province People's HospitalRecruiting
  • Henan Cancer HospitalRecruiting
  • Hunan Cancer HospitalRecruiting
  • The Affiliated Hospital of Xuzhou Medical CollegeRecruiting
  • The First Affiliated Hospital of Nanchang UniversityRecruiting
  • The Second Affiliated Hospital of Nanchang UniversityRecruiting
  • Tianjin Medical University Cancer Institute and HospitalRecruiting
  • Affiliated Tumor Hospital of Xinjiang Medical UniversityRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • Zhejiang Provincial Taizhou HospitalRecruiting
  • Beijing HospitalRecruiting
  • Shanghai Jiaotong University School of Medicine Ruijin HospitalRecruiting
  • Fudan University Shanghai Cancer CenterRecruiting
  • Blood Institute of the Chinese Academy of Medical scienceRecruiting
  • University Hospital Split
  • Division of Hematology, Dept. of Internal Medicine, University Hospital Centre Zagreb
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Hradec Kralove
  • Vseobecna fakultni nemocnice v Praze
  • CHU De Grenoble Hopital Albert Michallon
  • Hospital AVICENNE
  • Centre Hospitalier Lyon Sud
  • CHD Vendee
  • Chu Nimes/Institut De Cancerologie Du Gard
  • Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
  • CHRU De Tours
  • Centre Hospitalier de la Côte Basque
  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
  • CHRU de Brest - Hôpital Morvan
  • Centre Hospitalier du Mans
  • Hopital Saint Vincent De Paul
  • Ch Perpignan
  • Pole Regionalde Cancérologie(CHU de Poitiers)
  • Universitätsklinikum Heidelberg
  • Universitätsklinikum Ulm
  • Uniklinik Köln
  • Universitätsmedizin Mainz III. Medizinische Klinik und Poliklinik
  • München Klinik Schwabing
  • Universitätsklinikum Schleswig-Holstein
  • Lübecker Onkologische Schwerpunktpraxis
  • Charité Campus Virchow-Klinikum
  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
  • Debreceni Egyetem Klinikai Kozpont
  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  • University of Pecs 1st. Internalmedicin Clinic Dept
  • Mater Misericordiae Hospital
  • St James's Hosptial
  • Beaumont Hospital, Dublin
  • Rabin Medical Center
  • Soroka Medical Center
  • Laniado Medical Center
  • Tel Aviv Sourasky Medical Center
  • Carmel Hospital
  • Irccs Istituto Tumori Giovanni Paolo Ii
  • ASST-Monza -U.O Ematologia Adulti
  • Azienda Ospedaliero Universitaria Pisana
  • Irccs Crob
  • AULSS8 Berica-Ospedale S.Bortolo
  • Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
  • ASST Spedali Civili - Università degli Studi
  • A.O.U. Policlinico G.Rodolico - S. Marco
  • Azienda Ospedaliera Pugliese Ciaccio
  • Azienda Ospedaliera Universitaria Careggi
  • IRCCS Ospedale Policlinico San Martino
  • Ospedale Papardo
  • IRCCS Ospedale San Raffaele
  • ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
  • A.O.U. di Modena
  • Fondazione IRCCS Policlinico San Matteo
  • Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)
  • Ospedale Santa Maria delle Croci
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
  • Azienda Ospedaliera Santa Maria Terni
  • A.O.U. Citta' della Salute e della Scienza di Torino
  • Az. Osp. "Card G Panico"
  • Azienda Sanitaria Universitaria Giuliano Isontina
  • Ospedale Policlinico Giambattista Rossi, Borgo Roma
  • Nagoya Medical Center
  • Aichi Cancer Center Hospital
  • Nagoya City University Hospital
  • Ogaki Municipal Hospital
  • Hokkaido University Hospital
  • Kobe City Medical Center General Hospital
  • Tokai University Hospital- Isehara Campus
  • Kochi Medical School Hospital
  • NHO Sendai Medical Center
  • Tohoku University Hospital
  • Kindai University Hospital
  • Saitama Medical Center
  • Japanese Foundation for Cancer Research
  • NTT Medical Center Tokyo
  • JCHO Kyushu Hospital
  • Kumamoto University Hospital
  • Okayama University Hospital
  • Osaka University Hospital
  • Gachon University Gil Hospital
  • Pusan National University Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • The Catholic University of Korea-Seoul St. Mary's Hospital
  • Inje Univ Busan Paik Hospital
  • Wojewodzki Szpital Specjalistyczny
  • Centrum Onkologii Ziemi Lubelskiej
  • Uniwersyteckie Centrum Kliniczne
  • Szpitale Pomorskie Sp. z o. o.
  • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza
  • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii
  • Pratia Onkologia Katowice
  • Pratia MCM Krakow
  • Oddzial Hematologiczny, Specjalistyczny Szpital im. dra Sokołowskiego w Wałbrzychu
  • Instytut Hematologii i Transfuzjologii
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
  • Uniwersytecki Szpital Kliniczny Klinika
  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii
  • Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
  • Federal State Budgetary Institution "Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medico-Biological Agency
  • Academician I.P. Pavlov First St-Petersburg State Medical University
  • Oncology Dispensary #2 of Krasnodar Region
  • Gleneagles Medical Centre
  • Hospital Duran I Reynals
  • Hospital Universitario de Toledo
  • Complejo Hospitalario Universitario de Santiago de Compostel
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario Quironsalud Madrid
  • Hospital General Universitario Gregorio Marañón
  • Hospital General de Albacete
  • Hospital Universitari Vall d'Hebron
  • Hospital Clinic de Barcelona
  • Hospital San Pedro de Alcántara
  • Hospital Universitario Infanta Leonor-INTERNAL MED
  • Hospital Universitario La Paz
  • Hospital Universitario Marques De Valdecilla
  • Hospital Universitario Virgen del Rocío
  • Hospital Universitario de Alava
  • Clinica di Ematologia IOSI, Ospedale Bellinzona e Valli, Ente Ospedaliero Cantonale
  • China Medical University Hospital
  • Tri-Service General Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Memorial Hospital - Linkou
  • Ankara University Medicine Hospital
  • Istanbul University Istanbul Medicine Faculty
  • Erciyes University Faculty of Medicine
  • Gazi University Faculty of Medicine
  • Ege University Medical Faculty
  • Dokuz Eylul University Faculty of Medicine
  • Aberdeen Royal Infirmary
  • The Royal Cornwall Hospital
  • Derriford Hospital
  • Castle Hill Hospital
  • University College London Hospitals
  • Norfolk and Norwich Hospital
  • Singleton Hospital
  • Western General Hospital
  • Royal Marsden Hospital
  • St Johns Hospital at Howden
  • St James's University Hospital
  • Milton Keynes University Hospital
  • GenesisCare Cambridge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A (LOXO-305)

Arm B (Idelalisib plus rituximab [IdelaR] or bendamustine plus rituximab [BR])

Arm Description

Orally

Investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR).

Outcomes

Primary Outcome Measures

To evaluate progression-free survival (PFS) of LOXO-305 monotherapy (Arm A) compared to investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) (Arm B)
Assessed per iwCLL 2018

Secondary Outcome Measures

To evaluate the effectiveness of Arm A compared to Arm B based on Overall Response Rate (ORR)
Assessed per iwCLL 2018
To evaluate the effectiveness of Arm A compared to Arm B based on Overall Survival (OS)
Assessed by survival
To evaluate the effectiveness of Arm A compared to Arm B based on Time to Next Treatment (TTNT)
Defined as time from randomization to next systemic anticancer therapy for CLL/SLL
Time to worsening (TTW) of CLL/SLL related symptoms
Using symptom questions identified from the EORTC item library. The range of raw scores for these items could be from 0 to 52 with highest score being worse symptoms
Time to worsening (TTW) of physical function
Using the 5 physical function items identified from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) questionnaire (also known as the EORTC IL 19 questionnaire), physical function will be measured. The range of raw scores for these items could be from 0-20 with the highest score indicating worst function.

Full Information

First Posted
December 7, 2020
Last Updated
June 28, 2023
Sponsor
Loxo Oncology, Inc.
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04666038
Brief Title
Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Acronym
BRUIN CLL-321
Official Title
A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2027 (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 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.
Detailed Description
This is a Phase 3 global, randomized, open-label study comparing LOXO-305 (Arm A) to investigator's choice of either idelalisib plus rituximab or bendamustine plus rituximab (Arm B) in CLL/SLL patients who have been treated with at least a covalent BTK inhibitor (BTKi). Patients may have discontinued the prior covalent BTKi due to disease progression (PD) or intolerance. Patients who have received venetoclax are eligible for the study. Eligible patients will be randomized in 1:1 to Arm A and Arm B.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Keywords
Hematologic Disease, Lymphoma, non-Hodgkin's, Lymphoma, B-cell, Lymphoma, Bruton's tyrosine kinase inhibitor, Ibrutinib, Acalabrutinib, Zanubrutinib, Pirtobrutinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Eligible patients will be randomized in 1:1 into Arm A or Arm B. Patients randomized to Arm B who have disease progression (PD) confirmed by independent review committee (IRC) may be eligible to crossover into Arm A. Patients who discontinue treatment for toxicity may still be evaluated for cross over at the time of IRC-confirmed PD.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (LOXO-305)
Arm Type
Experimental
Arm Description
Orally
Arm Title
Arm B (Idelalisib plus rituximab [IdelaR] or bendamustine plus rituximab [BR])
Arm Type
Active Comparator
Arm Description
Investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR).
Intervention Type
Drug
Intervention Name(s)
LOXO-305
Other Intervention Name(s)
Pirtobrutinib
Intervention Description
Oral LOXO-305
Intervention Type
Drug
Intervention Name(s)
Idelalisib
Other Intervention Name(s)
Zydelig
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Treanda, Treakisym, Ribomustin, Levact
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan, MabThera, Truxima
Intervention Description
IV
Primary Outcome Measure Information:
Title
To evaluate progression-free survival (PFS) of LOXO-305 monotherapy (Arm A) compared to investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) (Arm B)
Description
Assessed per iwCLL 2018
Time Frame
Up to approximately 36 months
Secondary Outcome Measure Information:
Title
To evaluate the effectiveness of Arm A compared to Arm B based on Overall Response Rate (ORR)
Description
Assessed per iwCLL 2018
Time Frame
Up to approximately 36 months
Title
To evaluate the effectiveness of Arm A compared to Arm B based on Overall Survival (OS)
Description
Assessed by survival
Time Frame
Up to approximately 36 months
Title
To evaluate the effectiveness of Arm A compared to Arm B based on Time to Next Treatment (TTNT)
Description
Defined as time from randomization to next systemic anticancer therapy for CLL/SLL
Time Frame
Up to approximately 36 months
Title
Time to worsening (TTW) of CLL/SLL related symptoms
Description
Using symptom questions identified from the 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 36 months
Title
Time to worsening (TTW) of physical function
Description
Using the 5 physical function items identified from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) questionnaire (also known as the EORTC IL 19 questionnaire), physical function will be measured. The range of raw scores for these items could be from 0-20 with the highest score indicating worst function.
Time Frame
Up to approximately 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of CLL/SLL requiring therapy as defined by iwCLL 2018 criteria. Previously treated with a covalent BTK inhibitor. Eastern Cooperative Oncology Group (ECOG) 0-2. Absolute neutrophil count ≥ 0.75 × 10^9/L without granulocyte-colony-stimulating factor support, or ≥ 0.50 × 10^9/L in patients with documented bone marrow involvement considered to impair hematopoiesis. Granulocyte-colony-stimulating factor support is permitted in patients with documented bone marrow involvement. Hemoglobin ≥ 8 g/dL or ≥ 6 g/dL in patients with documented bone marrow involvement considered to impair hematopoiesis. Transfusion support is permitted in patients with bone marrow involvement. Platelets ≥ 50 × 10^9/L. If an investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be ≥ 75 × 10^9/L. Patients may enroll below these thresholds if the Investigator determines the cytopenia is related to bone marrow involvement considered to impair hematopoiesis. Patients with a platelet count < 30 x 10^9/L are excluded. AST and ALT ≤ 3.0 x upper limit of normal (ULN). Total bilirubin ≤ 1.5 x ULN. Estimated creatinine clearance of ≥ 30 mL/min. Exclusion Criteria: Known or suspected Richter's transformation at any time preceding enrollment. Known or suspected history of central nervous system (CNS) involvement by CLL/SLL. Ongoing drug-induced liver injury. Active uncontrolled auto-immune cytopenia. Significant cardiovascular disease. History of allogeneic or stem cell transplantation (SCT) or chimeric antigen receptor-modified T cells (CAR-T) therapy within the past 60 days. Active hepatitis B or hepatitis C. Known active cytomegalovirus (CMV) infection. Active uncontrolled systemic bacterial, viral, fungal or parasitic infection. Known Human Immunodeficiency Virus (HIV) infection, regardless of CD4 count. Clinically significant active malabsorption syndrome or inflammatory bowel disease Prior exposure to non-covalent (reversible) BTK inhibitor. Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist. Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers. Vaccination with a live vaccine within 28 days prior to randomization. Patients with the following hypersensitivity: Known hypersensitivity, including anaphylaxis, to any component or excipient of LOXO-305. For patients planned to receive idelalisib, known hypersensitivity, including anaphylaxis, to any component or excipient of idelalisib. For patients planned to receive bendamustine, known hypersensitivity, including anaphylaxis, to any component or excipient of bendamustine. Prior significant hypersensitivity to rituximab.
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
Marisa Hill, MD
Organizational Affiliation
Loxo Oncology, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Southern Cancer Center, P.C.
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mitchell Cancer Institute -University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Palo Verde Hematology Oncology
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85304
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Arizona Oncology Associates, P.C. - HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Orange Coast Memorial Medical Center
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
California Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Rocky Mountain Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical Oncology Hematology Consultants, PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Boca Raton Regional Hospital
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cancer Specialists of North Florida -St Augustine
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Oncology-Hematology Associates of West Broward
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
WellStar Health System
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Illinois Cancer Specialists-Niles
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Community Health Network
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Arnett Cancer Center
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47904
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Kentucky Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40563
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mercy Health-Paducah Medical Oncology and Hematology
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cancer Center Office of Clinical Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Greenebaum Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Ascension St. John Hospital
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Minnesota Oncology/Hematology PA
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
St. Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Nebraska Hematology-Oncology
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
New Jersey Center for Cancer Research
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Alliance, Inc.
City
Westbury
State/Province
New York
ZIP/Postal Code
11590
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Oncology Hematology Care Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Willamette Valley Cancer Institute and Research Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Carolina Blood and Cancer Care Associates
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Oncology - Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Oncology Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Oncology - Medical City Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Oncology - Dallas Presbyterian Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Oncology Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The Center for Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Oncology - McAllen
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Oncology - San Antonio Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Virginia Cancer Specialists, PC
City
Gainesville
State/Province
Virginia
ZIP/Postal Code
20155
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Oncology and Hematology Associates of Southwest Virginia Inc
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Northwest Medical Specialties, PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
St Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
The St. George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Ingham Institute of Medical Research
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
NSW2170
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Westmead Hospital
City
Wentworthville
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Ordensklinikum Linz GmbH Elisabethinen
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Active, not recruiting
Facility Name
Uniklinikum Salzburg
City
Salzburg
State/Province
Osterreich
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Active, not recruiting
Facility Name
Medizinische Universität Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Active, not recruiting
Facility Name
CHR Verviers-Onco
City
Verviers
State/Province
Liege
ZIP/Postal Code
4800
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
VITAZ
City
Sint-Niklaas
State/Province
Oost-Vlaanderen
ZIP/Postal Code
B-9100
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
AZ Delta
City
Roeselare
State/Province
West Flanders
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Groupe Jolimont
City
Haine-Saint-Paul
ZIP/Postal Code
7100
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
AZ St-Elisabeth
City
Herentals
ZIP/Postal Code
2200
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Clinique Saint Pierre Ottignies
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Cancer Care Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Queen Elizabeth II Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Princess Margaret Hospital (Ontario)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8618210264969
First Name & Middle Initial & Last Name & Degree
Yujun Dong
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8613910556677
First Name & Middle Initial & Last Name & Degree
Xiaoyan Ke
Facility Name
Xuanwu Hospital Capital Medical University
City
Xicheng District
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8613691066953
First Name & Middle Initial & Last Name & Degree
Wuhan Hui
Facility Name
Gansu Province Cancer Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730050
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+86-13993162602
First Name & Middle Initial & Last Name & Degree
Jie Cui
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
862087343356
First Name & Middle Initial & Last Name & Degree
He Huang
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
Hainan Province People's Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570100
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8613976595976
First Name & Middle Initial & Last Name & Degree
Lie Lin
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
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 Affiliated Hospital of Xuzhou Medical College
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221006
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8618052268791
First Name & Middle Initial & Last Name & Degree
Jiang Cao
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
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8618679124515
First Name & Middle Initial & Last Name & Degree
Yu Li
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8618622221227
First Name & Middle Initial & Last Name & Degree
Lihua Qiu
Facility Name
Affiliated Tumor Hospital of Xinjiang Medical University
City
Ürümqi
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
Zhejiang Provincial Taizhou Hospital
City
Linhai
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8613515861286
First Name & Middle Initial & Last Name & Degree
Qun Yi Guo
Facility Name
Beijing Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8613520618812
First Name & Middle Initial & Last Name & Degree
Liu Hui
Facility Name
Shanghai Jiaotong University School of Medicine Ruijin Hospital
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+8613901651262
First Name & Middle Initial & Last Name & Degree
Junmin Li
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
+862164036901
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
University Hospital Split
City
Split
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Active, not recruiting
Facility Name
Division of Hematology, Dept. of Internal Medicine, University Hospital Centre Zagreb
City
Zagreb
Country
Croatia
Individual Site Status
Active, not recruiting
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
CHU De Grenoble Hopital Albert Michallon
City
Grenoble
State/Province
Cedex 09
ZIP/Postal Code
38043
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hospital AVICENNE
City
Bobigny
State/Province
Cedex
ZIP/Postal Code
93 009
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
State/Province
Cedex
ZIP/Postal Code
69495
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHD Vendee
City
La Roche-sur-Yon
State/Province
La Roche Sur Yon
ZIP/Postal Code
85000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Chu Nimes/Institut De Cancerologie Du Gard
City
Nîmes
State/Province
Nimes
ZIP/Postal Code
30900
Country
France
Individual Site Status
Active, not recruiting
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
Active, not recruiting
Facility Name
CHRU De Tours
City
Tours
State/Province
Tours Cedex 9
ZIP/Postal Code
37044
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Hospitalier de la Côte Basque
City
Bayonne
ZIP/Postal Code
64109
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHRU de Brest - Hôpital Morvan
City
Brest cedex
ZIP/Postal Code
29609
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Hospitalier du Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hopital Saint Vincent De Paul
City
Lille cedex
ZIP/Postal Code
59020
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Ch Perpignan
City
Perpignan
ZIP/Postal Code
66046
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Pole Regionalde Cancérologie(CHU de Poitiers)
City
Politiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Ulm
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Uniklinik Köln
City
Kerpener
State/Province
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsmedizin Mainz III. Medizinische Klinik und Poliklinik
City
Langenbeckstraße 1
State/Province
Mainz
ZIP/Postal Code
D- 55131
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
München Klinik Schwabing
City
Koelner Platz 1
State/Province
München
ZIP/Postal Code
80804
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Lübecker Onkologische Schwerpunktpraxis
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23562
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
University of Pecs 1st. Internalmedicin Clinic Dept
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Mater Misericordiae Hospital
City
Dublin 7
Country
Ireland
Individual Site Status
Active, not recruiting
Facility Name
St James's Hosptial
City
Dublin 8
ZIP/Postal Code
D08 NHY1
Country
Ireland
Individual Site Status
Active, not recruiting
Facility Name
Beaumont Hospital, Dublin
City
Dublin
ZIP/Postal Code
DUBLIN 9
Country
Ireland
Individual Site Status
Active, not recruiting
Facility Name
Rabin Medical Center
City
Petah Tikva
State/Province
HaMerkaz
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Soroka Medical Center
City
Beer Sheva
ZIP/Postal Code
8457108
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Laniado Medical Center
City
Netanya
ZIP/Postal Code
4244916
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Carmel Hospital
City
Haifa
State/Province
Ḥeifā
ZIP/Postal Code
3436212
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Irccs Istituto Tumori Giovanni Paolo Ii
City
Viale Orazio Flacco
State/Province
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
ASST-Monza -U.O Ematologia Adulti
City
Monza (MB) -Settore E
State/Province
Piano 2
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
State/Province
PI
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Irccs Crob
City
Rionero In Vulture
State/Province
Potenza
ZIP/Postal Code
85028
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
AULSS8 Berica-Ospedale S.Bortolo
City
Vicenza
State/Province
Veneto
ZIP/Postal Code
36100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
City
Alessandria
ZIP/Postal Code
15100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
ASST Spedali Civili - Università degli Studi
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
A.O.U. Policlinico G.Rodolico - S. Marco
City
Catania
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Pugliese Ciaccio
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
IRCCS Ospedale Policlinico San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale Papardo
City
Messina
ZIP/Postal Code
98158
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
A.O.U. di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale Santa Maria delle Croci
City
Ravenna
ZIP/Postal Code
48020
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Santa Maria Terni
City
Terni
ZIP/Postal Code
05100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
A.O.U. Citta' della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Az. Osp. "Card G Panico"
City
Tricase
ZIP/Postal Code
4 - 73039
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Sanitaria Universitaria Giuliano Isontina
City
Trieste
ZIP/Postal Code
34125
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale Policlinico Giambattista Rossi, Borgo Roma
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Nagoya Medical Center
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Aichi Cancer Center Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Ogaki Municipal Hospital
City
Ogaki-shi
State/Province
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tokai University Hospital- Isehara Campus
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1143
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kochi Medical School Hospital
City
Nankoku
State/Province
Kochi
ZIP/Postal Code
783-8505
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
NHO Sendai Medical Center
City
Sendai-shi
State/Province
Miyagi-Ken
ZIP/Postal Code
983-8520
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tohoku University Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kindai University Hospital
City
Osaka Sayama-shi
State/Province
Osaka
ZIP/Postal Code
589 8511
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Saitama Medical Center
City
Kawagoe
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Japanese Foundation for Cancer Research
City
Koto
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
NTT Medical Center Tokyo
City
Shinagawa-Ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
JCHO Kyushu Hospital
City
Fukoka-ken
ZIP/Postal Code
806 8501
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Active, not recruiting
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
Active, not recruiting
Facility Name
Pusan National University Hospital
City
Busan
State/Province
Pusan-Kwangyǒkshi
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul, Korea
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
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
Active, not recruiting
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
Active, not recruiting
Facility Name
Inje Univ Busan Paik Hospital
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Wojewodzki Szpital Specjalistyczny
City
Iwaszkiewicza 5
State/Province
Legnica
ZIP/Postal Code
59-220
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Centrum Onkologii Ziemi Lubelskiej
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-081
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Szpitale Pomorskie Sp. z o. o.
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-519
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza
City
Brzozów
ZIP/Postal Code
36-200
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Pratia Onkologia Katowice
City
Katowice
ZIP/Postal Code
40519
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Pratia MCM Krakow
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Oddzial Hematologiczny, Specjalistyczny Szpital im. dra Sokołowskiego w Wałbrzychu
City
Walbrzych
ZIP/Postal Code
58-309
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Instytut Hematologii i Transfuzjologii
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Uniwersytecki Szpital Kliniczny Klinika
City
Wrocław
ZIP/Postal Code
50-367
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii
City
Łódź
ZIP/Postal Code
93510
Country
Poland
Individual Site Status
Active, not recruiting
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
Active, not recruiting
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
Active, not recruiting
Facility Name
Academician I.P. Pavlov First St-Petersburg State Medical University
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Oncology Dispensary #2 of Krasnodar Region
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Gleneagles Medical Centre
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
258499
Country
Singapore
Individual Site Status
Active, not recruiting
Facility Name
Hospital Duran I Reynals
City
Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario de Toledo
City
Toledo
State/Province
Castilla La Mancha
ZIP/Postal Code
45004
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Complejo Hospitalario Universitario de Santiago de Compostel
City
Santiago de Compostela
State/Province
La Coruna
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Quironsalud Madrid
City
Pozuelo De Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
State/Province
Planta Baja
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital General de Albacete
City
Albacete
ZIP/Postal Code
02006
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital San Pedro de Alcántara
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Infanta Leonor-INTERNAL MED
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Marques De Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario de Alava
City
Vitoria
ZIP/Postal Code
01005
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Clinica di Ematologia IOSI, Ospedale Bellinzona e Valli, Ente Ospedaliero Cantonale
City
Bellinzona
State/Province
Svizzera
ZIP/Postal Code
6500
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
China Medical University Hospital
City
Taichung City
State/Province
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Tri-Service General Hospital
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
112201
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Chang Gung Memorial Hospital - Linkou
City
Taoyuan, (r.o.c.)
ZIP/Postal Code
33342
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Ankara University Medicine Hospital
City
Mamak
State/Province
Ankara
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Istanbul University Istanbul Medicine Faculty
City
Faith
State/Province
Istanbul
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Erciyes University Faculty of Medicine
City
Kayseri
State/Province
Melikgazi
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Gazi University Faculty of Medicine
City
Ankara
State/Province
Yenimahalle
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Dokuz Eylul University Faculty of Medicine
City
Izmir
ZIP/Postal Code
35330
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Aberdeen City
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
The Royal Cornwall Hospital
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Derriford Hospital
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Castle Hill Hospital
City
Cottingham
State/Province
East Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
University College London Hospitals
City
London
State/Province
Greater London
ZIP/Postal Code
WC1E 6HX
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Norfolk and Norwich Hospital
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Singleton Hospital
City
Swansea
State/Province
Sa2 8qa
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
St Johns Hospital at Howden
City
Livingston
State/Province
West Lothian
ZIP/Postal Code
EH54 6PP
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
St James's University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Milton Keynes University Hospital
City
Milton Keynes
ZIP/Postal Code
MK6 5LD
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
GenesisCare Cambridge
City
Newmarket
ZIP/Postal Code
CB8 7XN
Country
United Kingdom
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

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