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A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-313)

Primary Purpose

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pirtobrutinib
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 BTKi, BTK Inhibitor, Hematologic Disease, Lymphoma, non-Hodgkin's, Lymphoma, B-cell

Eligibility Criteria

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

Inclusion Criteria:

  • Confirmed diagnosis of CLL/SLL requiring therapy, per iwCLL 2018 criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Adequate organ function
  • Platelets greater than or equal to (≥)75 x 10⁹/liter (L) (≥50 × 10⁹/L for patients with evidence of bone marrow infiltrate), hemoglobin ≥8 grams/deciliter (g/dL), and absolute neutrophil count ≥0.75 x 10⁹/L
  • Kidney function: Estimated creatinine clearance ≥40 milliliters per minute (mL/min)

Exclusion Criteria:

  • Known or suspected Richter's transformation at any time preceding enrollment
  • Prior systemic therapy for CLL/SLL
  • Presence of 17p deletion
  • Central nervous system (CNS) involvement
  • Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
  • Significant cardiovascular disease
  • Active hepatitis B or hepatitis C
  • Active cytomegalovirus (CMV) infection
  • Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  • Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
  • Concurrent use of investigational agent or anticancer therapy except hormonal therapy
  • Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
  • 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 pirtobrutinib or bendamustine
    • Prior significant hypersensitivity to rituximab

Sites / Locations

  • California Research Institute
  • Innovative Clinical Research Institute
  • Oncology-Hematology Associates of West Broward
  • Central Maine Medical Center
  • Ascension St. John Hospital
  • New Jersey Center for Cancer Research
  • Clinical Research Alliance, Inc.
  • Liverpool Hospital
  • Westmead Hospital
  • Peninsula Private Hospital
  • Uniklinikum Salzburg
  • Klinik Ottakring
  • Centro Integrado de Oncologia de Curitiba
  • Instituto do Câncer - Hospital São Vicente de Paulo
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre
  • Centro Gaucho Integrado - Mae de Deus Center
  • Hemocentro Unicamp
  • Fundação Doutor Amaral Carvalho
  • UMHAT "Sveti Georgi" EAD
  • UMHAT 'Sv. Ivan Rilski', EAD
  • "SHATHD" EAD, Sofia
  • UMHAT - Prof. Dr. Stoyan Kirkovich" AD
  • Anhui Provincial Cancer HospitalRecruiting
  • Peking University First HospitalRecruiting
  • Peking University Third HospitalRecruiting
  • Cancer Center of Guangzhou Medical UniversityRecruiting
  • The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
  • Hunan Cancer HospitalRecruiting
  • The First Affiliated Hospital of Nanchang UniversityRecruiting
  • Shengjing Hospital of China Medical UniversityRecruiting
  • Jiangsu Province HospitalRecruiting
  • Shanghai Tongren HospitalRecruiting
  • West China Hospital of Sichuan UniversityRecruiting
  • Institute of hematology&blood disease hospitalRecruiting
  • Tianjin Medical University Cancer Institute and HospitalRecruiting
  • The First People's Hospital of Hangzhou Linping DistrictRecruiting
  • Beijing HospitalRecruiting
  • Chongqing Cancer HospitalRecruiting
  • Hainan General HospitalRecruiting
  • Henan Cancer HospitalRecruiting
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Hradec Kralove
  • Fakultni nemocnice Kralovske Vinohrady
  • Vseobecna fakultni nemocnice v Praze
  • CHRU De Tours
  • CHD Vendee
  • Hospitalier Le Mans
  • Chu Nimes/Institut De Cancerologie Du Gard
  • Semmelweis Egyetem
  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
  • National Institute of Oncology
  • Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Mater Misericordiae Hospital
  • IRCCS - AOU di Bologna
  • Azienda Ospedaliero Universitaria Pisana
  • Irccs Crob
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
  • Azienda Ospedaliera Universitaria Careggi
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
  • ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
  • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
  • Azienda Ospedale Maggiore Della Carita
  • Azienda Ospedaliera Vincenzo Cervello
  • Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)
  • Ospedale Santa Maria delle Croci
  • Fondazione Policlinico Universitario Agostino Gemelli
  • Azienda Ospedaliera Santa Maria Terni
  • A.O.U. Citta' della Salute e della Scienza di Torino
  • Azienda Ospedaliera Card. G. Panico
  • Azienda sanitaria integrata università di Trieste
  • Nagoya Medical Center
  • Nagoya City University Hospital
  • Chiba Cancer Center
  • Fukui Medical University Hospital
  • Our Lady of the Snow St. Mary's Hospital
  • Hospital of University of Occupational and Environmental Health
  • NHO Mito Medical Center
  • Hokkaido University Hospital
  • Kanagawa cancer center
  • Kochi Medical School Hospital
  • Tohoku University Hospital
  • Saitama Medical Center
  • Dokkyo Medical University - Koshigaya Hospital
  • University of Yamanashi Hospital
  • JCHO Kyushu Hospital
  • Kagoshima University Hospital
  • Okayama University Hospital
  • Gachon University Gil Medical Center
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • The Catholic University of Korea-Seoul St. Mary's Hospital
  • Inje Univ Busan Paik Hospital
  • North Shore Hospital, Haematology Research
  • Tauranga Hospital
  • Christchurch Hospital
  • Middlemore Clinical Trials
  • Wojewodzki Szpital Specjalistyczny
  • Klinika Hematoonkologii i Transplantacji Szpiku SPSK1 Lublin
  • Uniwersyteckie Centrum Kliniczne
  • Centrum Medyczne Pratia Poznan
  • KO-MED Centra Kliniczne
  • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii
  • Pratia Onkologia Katowice
  • Pratia MCM Krakow
  • Centrum Onkologii Ziemi Lubelskiej
  • Szpital Wojewodzki w Opolu
  • Nasz Lekarz Osrodek Badan Klinicznych
  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Cuire - Państwowy Instytut Badawczy
  • Uniwersytecki Szpital Kliniczny Klinika
  • Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
  • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE
  • Hospital de Sao Joao E.P.E.
  • Centro Hospitalar de Vila Nova de Gaia
  • Spitalul Clinic Municipal Filantropia Craiova
  • Spitalul Clinic Colentina
  • Institutul Clinic Fundeni - Centrul de Hematologie si Transplant Medular
  • Spitalul Clinic Coltea
  • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
  • Institutului Regional de Oncologie IASI
  • Spitalul Clinic Judetean De Urgenta Oradea
  • Spitalul Clinic Judetean de Urgenta Targu Mures
  • Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
  • Regional Oncology Dispensary
  • Academician I.P. Pavlov First St-Petersburg State Medical University
  • Hospital Universitario Central de Asturias
  • Hospital Universitario HM Sanchinarro
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Duran I Reynals
  • Hospital Universitario Fundación Jiménez Díaz
  • Hospital Universitario Virgen del Rocío
  • Hospital Universitario Virgen de Valme
  • Chang Bing Show Chwan Memorial Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • China Medical University Hospital
  • National Taiwan University Hospital
  • Chang Gung Memorial Hospital - Linkou
  • Birmingham Heartlands Hospital
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A (Pirtobrutinib)

Arm B (BR)

Arm Description

Pirtobrutinib administered orally

Bendamustine plus rituximab administered intravenously (IV)

Outcomes

Primary Outcome Measures

To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine and rituximab (Arm B)
Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Response Criteria

Secondary Outcome Measures

To evaluate the effectiveness of Arm A compared to Arm B: Progression-free survival (PFS)
Assessments of effectiveness include PFS, assessed by investigator
To evaluate the effectiveness of Arm A compared to Arm B: Overall survival (OS)
Assessments of effectiveness include OS, assessed by investigator
To evaluate the effectiveness of Arm A compared to Arm B: Time to next treatment (TTNT)
Assessments of effectiveness include TTNT, assessed by investigator
To evaluate the effectiveness of Arm A compared to Arm B: Overall response rate (ORR)
Assessments of effectiveness include ORR, assessed by investigator and IRC
To evaluate the effectiveness of Arm A compared to Arm B: Duration of Response (DOR)
Assessments of effectiveness include DOR, assessed by investigator and IRC
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported disease-related symptoms
Based on time to worsening of CLL/SLL-related symptoms
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported physical functioning
Based on time to worsening of physical functioning

Full Information

First Posted
August 24, 2021
Last Updated
July 8, 2023
Sponsor
Loxo Oncology, Inc.
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05023980
Brief Title
A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Acronym
BRUIN CLL-313
Official Title
A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2021 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
July 2026 (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
The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.

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
BTKi, BTK Inhibitor, Hematologic Disease, Lymphoma, non-Hodgkin's, Lymphoma, B-cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Eligible patients will be randomized 1:1 into Arm A and 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (Pirtobrutinib)
Arm Type
Experimental
Arm Description
Pirtobrutinib administered orally
Arm Title
Arm B (BR)
Arm Type
Active Comparator
Arm Description
Bendamustine plus rituximab administered intravenously (IV)
Intervention Type
Drug
Intervention Name(s)
Pirtobrutinib
Other Intervention Name(s)
LOXO-305, LY3527727
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, Riabni, Ruxience
Intervention Description
IV
Primary Outcome Measure Information:
Title
To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine and rituximab (Arm B)
Description
Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Response Criteria
Time Frame
Up to approximately 5 years
Secondary Outcome Measure Information:
Title
To evaluate the effectiveness of Arm A compared to Arm B: Progression-free survival (PFS)
Description
Assessments of effectiveness include PFS, assessed by investigator
Time Frame
Up to approximately 5 years
Title
To evaluate the effectiveness of Arm A compared to Arm B: Overall survival (OS)
Description
Assessments of effectiveness include OS, assessed by investigator
Time Frame
Up to approximately 5 years
Title
To evaluate the effectiveness of Arm A compared to Arm B: Time to next treatment (TTNT)
Description
Assessments of effectiveness include TTNT, assessed by investigator
Time Frame
Up to approximately 5 years
Title
To evaluate the effectiveness of Arm A compared to Arm B: Overall response rate (ORR)
Description
Assessments of effectiveness include ORR, assessed by investigator and IRC
Time Frame
Up to approximately 5 years
Title
To evaluate the effectiveness of Arm A compared to Arm B: Duration of Response (DOR)
Description
Assessments of effectiveness include DOR, assessed by investigator and IRC
Time Frame
Up to approximately 5 years
Title
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported disease-related symptoms
Description
Based on time to worsening of CLL/SLL-related symptoms
Time Frame
Up to approximately 5 years
Title
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported physical functioning
Description
Based on time to worsening of physical functioning
Time Frame
Up to approximately 5 years

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, per iwCLL 2018 criteria Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 Adequate organ function Platelets greater than or equal to (≥)75 x 10⁹/liter (L) (≥50 × 10⁹/L for patients with evidence of bone marrow infiltrate), hemoglobin ≥8 grams/deciliter (g/dL), and absolute neutrophil count ≥0.75 x 10⁹/L Kidney function: Estimated creatinine clearance ≥40 milliliters per minute (mL/min) Exclusion Criteria: Known or suspected Richter's transformation at any time preceding enrollment Prior systemic therapy for CLL/SLL Presence of 17p deletion Central nervous system (CNS) involvement Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP]) Significant cardiovascular disease Active hepatitis B or hepatitis C Active cytomegalovirus (CMV) infection Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count Concurrent use of investigational agent or anticancer therapy except hormonal therapy Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist 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 pirtobrutinib or 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
Alex Levy, MD
Organizational Affiliation
Loxo Oncology
Official's Role
Study Director
Facility Information:
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
Innovative Clinical Research Institute
City
Whittier
State/Province
California
ZIP/Postal Code
90603
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
Central Maine Medical Center
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
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
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
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
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
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
Peninsula Private Hospital
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Uniklinikum Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Active, not recruiting
Facility Name
Klinik Ottakring
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Individual Site Status
Active, not recruiting
Facility Name
Centro Integrado de Oncologia de Curitiba
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80810050
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Instituto do Câncer - Hospital São Vicente de Paulo
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010090
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Irmandade da Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050-170
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Centro Gaucho Integrado - Mae de Deus Center
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90110270
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hemocentro Unicamp
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13083-878
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Fundação Doutor Amaral Carvalho
City
Jaú
State/Province
São Paulo
ZIP/Postal Code
17210120
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
UMHAT "Sveti Georgi" EAD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
UMHAT 'Sv. Ivan Rilski', EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
"SHATHD" EAD, Sofia
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
UMHAT - Prof. Dr. Stoyan Kirkovich" AD
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
8613625520213
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
18330935797
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
17778027193
First Name & Middle Initial & Last Name & Degree
Xiaoyan Ke
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
15927713804
First Name & Middle Initial & Last Name & Degree
Chuan Jin
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
8615625891843
First Name & Middle Initial & Last Name & Degree
Zhenqian Huang
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
15172405695
First Name & Middle Initial & Last Name & Degree
Guohui Cui
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
8613007403888
First Name & Middle Initial & Last Name & Degree
Hui Zhou
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
13657914239
First Name & Middle Initial & Last Name & Degree
Fei Li
Facility Name
Shengjing Hospital of China Medical University
City
Shenyany
State/Province
Liaoning
ZIP/Postal Code
110022
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
15942907003
First Name & Middle Initial & Last Name & Degree
Wei Yang
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Nanjing
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
8613951019464
First Name & Middle Initial & Last Name & Degree
Jianyong Li
Facility Name
Shanghai Tongren Hospital
City
Changning District
State/Province
Shanghai
ZIP/Postal Code
200050
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
19921055257
First Name & Middle Initial & Last Name & Degree
Ligen Liu
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
15281706453
First Name & Middle Initial & Last Name & Degree
Liqun Zou
Facility Name
Institute of hematology&blood disease hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
15222885931
First Name & Middle Initial & Last Name & Degree
Shuhua Yi
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
15022492653
First Name & Middle Initial & Last Name & Degree
Lihua Qiu
Facility Name
The First People's Hospital of Hangzhou Linping District
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
311100
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
15372002536
First Name & Middle Initial & Last Name & Degree
Yuefeng Zhang
Facility Name
Beijing Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
13756513114
First Name & Middle Initial & Last Name & Degree
HUI LIU
Facility Name
Chongqing Cancer Hospital
City
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
8618311611644
First Name & Middle Initial & Last Name & Degree
Jieping Li
Facility Name
Hainan General Hospital
City
Haikou
ZIP/Postal Code
570311
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
8618889624097
First Name & Middle Initial & Last Name & Degree
Lie Lin
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
18738196013
First Name & Middle Initial & Last Name & Degree
Keshu Zhou
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
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
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
CHRU De Tours
City
Tours
State/Province
Tours Cedex 9
ZIP/Postal Code
37044
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHD Vendee
City
La Roche-sur-Yon
State/Province
Vendee
ZIP/Postal Code
85000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hospitalier Le Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Chu Nimes/Institut De Cancerologie Du Gard
City
Nimes
ZIP/Postal Code
30900
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
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
National Institute of Oncology
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Székesfehérvár
ZIP/Postal Code
8000
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
IRCCS - AOU di Bologna
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
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
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
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
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
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
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
City
Monza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedale Maggiore Della Carita
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Vincenzo Cervello
City
Palermo
ZIP/Postal Code
90146
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
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
Azienda Ospedaliera Card. G. Panico
City
Tricase (Le)
ZIP/Postal Code
73039
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda sanitaria integrata università di Trieste
City
Trieste
ZIP/Postal Code
34125
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
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Chiba Cancer Center
City
Chiba-Shi
State/Province
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Fukui Medical University Hospital
City
Yoshida-Gun
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Our Lady of the Snow St. Mary's Hospital
City
Kurume-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
830 8543
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Hospital of University of Occupational and Environmental Health
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
807 8556
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
NHO Mito Medical Center
City
Ibaraki-machi
State/Province
HigaShiibaraki-Gun
ZIP/Postal Code
311 3193
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
Kanagawa cancer center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
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
Tohoku University Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
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
Dokkyo Medical University - Koshigaya Hospital
City
Koshigaya
State/Province
Saitama
ZIP/Postal Code
343 8555
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
University of Yamanashi Hospital
City
Chuo
State/Province
Yamanshi
ZIP/Postal Code
409-3821
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
Kagoshima University Hospital
City
Kagoshima
ZIP/Postal Code
890-8520
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
Gachon University Gil Medical Center
City
Namdong-gu
State/Province
Incheon-gwangyeoksi [Incheon]
ZIP/Postal Code
21565
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
Samsung Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
06351
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
North Shore Hospital, Haematology Research
City
Takapuna
State/Province
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Individual Site Status
Active, not recruiting
Facility Name
Tauranga Hospital
City
Tauranga
State/Province
Bay Of Plenty
ZIP/Postal Code
3112
Country
New Zealand
Individual Site Status
Active, not recruiting
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Active, not recruiting
Facility Name
Middlemore Clinical Trials
City
Papatoetoe
ZIP/Postal Code
2025
Country
New Zealand
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
Klinika Hematoonkologii i Transplantacji Szpiku SPSK1 Lublin
City
Lublin
State/Province
Lubelskie V
ZIP/Postal Code
20081
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80214
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Centrum Medyczne Pratia Poznan
City
Skorzewo
State/Province
Poznan
ZIP/Postal Code
60 185
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
KO-MED Centra Kliniczne
City
Biała Podlaska
ZIP/Postal Code
21500
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
Kraków
ZIP/Postal Code
30-510
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Centrum Onkologii Ziemi Lubelskiej
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Szpital Wojewodzki w Opolu
City
Opole
ZIP/Postal Code
45061
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Nasz Lekarz Osrodek Badan Klinicznych
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Cuire - Państwowy Instytut Badawczy
City
Warsaw
ZIP/Postal Code
02781
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
Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Active, not recruiting
Facility Name
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649035
Country
Portugal
Individual Site Status
Active, not recruiting
Facility Name
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Active, not recruiting
Facility Name
Hospital de Sao Joao E.P.E.
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Active, not recruiting
Facility Name
Centro Hospitalar de Vila Nova de Gaia
City
Vila Nova De Gaia
ZIP/Postal Code
4434-536
Country
Portugal
Individual Site Status
Active, not recruiting
Facility Name
Spitalul Clinic Municipal Filantropia Craiova
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200143
Country
Romania
Individual Site Status
Active, not recruiting
Facility Name
Spitalul Clinic Colentina
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Individual Site Status
Active, not recruiting
Facility Name
Institutul Clinic Fundeni - Centrul de Hematologie si Transplant Medular
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Active, not recruiting
Facility Name
Spitalul Clinic Coltea
City
Bucuresti
ZIP/Postal Code
030171
Country
Romania
Individual Site Status
Active, not recruiting
Facility Name
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Active, not recruiting
Facility Name
Institutului Regional de Oncologie IASI
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Individual Site Status
Active, not recruiting
Facility Name
Spitalul Clinic Judetean De Urgenta Oradea
City
Oradea
ZIP/Postal Code
410469
Country
Romania
Individual Site Status
Active, not recruiting
Facility Name
Spitalul Clinic Judetean de Urgenta Targu Mures
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
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
Regional Oncology Dispensary
City
Penza
ZIP/Postal Code
440071
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Academician I.P. Pavlov First St-Petersburg State Medical University
City
St-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Duran I Reynals
City
L'Hospitalet De Llobregat
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
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 Virgen de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Chang Bing Show Chwan Memorial Hospital
City
Changhua
ZIP/Postal Code
50544
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Chang Gung Memorial Hospital - Linkou
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://trials.lilly.com/en-US/trial/302156
Description
A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-313)

Learn more about this trial

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

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