search
Back to results

Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma

Primary Purpose

Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma (MCL), Relapsed Mantle Cell Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BGB-11417
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma focused on measuring Mantle Cell Lymphoma, Lymphoma, MCL, Refractory MCL, Refractory Mantle Cell Lymphoma, Relapsed Mantle Cell Lymphoma

Eligibility Criteria

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

Key Inclusion Criteria:

  1. Histologically confirmed diagnosis of MCL
  2. Prior systemic treatments for MCL (at least one line of anti-cluster of differentiate 20 (CD20) based immune or chemoimmunotherapy and at least one line of treatment with Bruton Tyrosine Kinase Inhibitor (BTKi) as mono- or combination therapy)
  3. relapsed/refractory disease
  4. Presence of measurable disease
  5. Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
  7. Adequate organ function

Key Exclusion Criteria:

  1. Known central nervous system involvement by lymphoma
  2. Prior malignancy other than MCL within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer.
  3. Prior exposure to a Bcl-2 inhibitor (eg, venetoclax/ABT-199).
  4. Prior autologous stem cell transplant within the last 3 months; or prior chimeric cell therapy within the last 3 months; or prior allogeneic stem cell transplant within the last 6 months or currently has an active graft-vs-host disease requiring the use of immunosuppressants.
  5. Clinically significant cardiovascular disease.
  6. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
  7. Active fungal, bacterial or viral infection requiring systemic treatment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • University of Alabama At Birmingham HospitalRecruiting
  • Des Moines Oncology Research AssociationRecruiting
  • Tulane Cancer CenterRecruiting
  • Maryland Oncology Hematology, PaRecruiting
  • Nebraska Cancer SpecialistsRecruiting
  • Dartmouth Cancer CenterRecruiting
  • Hackensack University Medical CenterRecruiting
  • Novant Health Hematology CharlotteRecruiting
  • The University of Texas Md Anderson Cancer CenterRecruiting
  • Hospital Erasto GaertnerRecruiting
  • Hospital Mae de DeusRecruiting
  • Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto UspRecruiting
  • Hospital Sao Rafael (Rede Dor)Recruiting
  • Instituto Dor de Pesquisa E Ensino Sao PauloRecruiting
  • Hcfmusp Servico de Hematologia, Hemoterapia E Terapia CelularRecruiting
  • Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province HospitalRecruiting
  • China Japan Friendship HospitalRecruiting
  • Beijing Cancer HospitalRecruiting
  • Beijing Friendship Hospital, Capital Medical University(Tongzhou)Recruiting
  • Fujian Cancer HospitalRecruiting
  • Sun Yat Sen University Cancer CenterRecruiting
  • Guangdong Provincial Peoples Hospital Huifu BranchRecruiting
  • Jiangmen Central HospitalRecruiting
  • The Tumor Hospital Affiliated to Guangxi Medical UniversityRecruiting
  • Cancer Hospital of Guizhou Medical UniversityRecruiting
  • Hainan General HospitalRecruiting
  • Henan Cancer HospitalRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • Tongji Hospital of Tongji Medical College Huazhong University of Science and TechnologyRecruiting
  • Jiangsu Province HospitalRecruiting
  • Affiliated Hospital of Nantong UniversityRecruiting
  • The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
  • The First Affiliated Hospital of Nanchang University Branch DonghuRecruiting
  • Jiangxi Province Cancer HospitalRecruiting
  • Liaoning Cancer Hospital and InstituteRecruiting
  • General Hospital of Ningxia Medical UniversityRecruiting
  • Shandong Cancer HospitalRecruiting
  • The Affiliated Hospital of Qingdao University Branch West CoastRecruiting
  • Shanxi Provincial Cancer HospitalRecruiting
  • West China Hospital, Sichuan UniversityRecruiting
  • Institute of Hematology and Hospital of Blood DiseaseRecruiting
  • Tianjin Medical University Cancer Institute and HospitalRecruiting
  • The First Peoples Hospital of KashgarRecruiting
  • Affiliated Cancer Hospital of Xinjiang Medical UniversityRecruiting
  • The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • Centre Hospitalier Le MansRecruiting
  • Centre Hospitalier Universitaire Nantes Hotel DieuRecruiting
  • Hopital Pitie Salpetriere Service HematologieRecruiting
  • Necker University HospitalRecruiting
  • Chu Hopital Lyon SudRecruiting
  • Chu Tours Hopital Bretonneau Service PneumologieRecruiting
  • Universitatsklinikum Koln, Innere Medizin IRecruiting
  • Assuta Ashdod Medical CenterRecruiting
  • Shaare Zedek Medical CenterRecruiting
  • Hadassah En Karem Medical CenterRecruiting
  • Rabin Medical CentreRecruiting
  • Sheba Medical CenterRecruiting
  • Tel Aviv Medical CenterRecruiting
  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IrstRecruiting
  • Aou Maggiore Della CaritaRecruiting
  • Uniwersyteckie Centrum KliniczneRecruiting
  • Pratia McM KrakowRecruiting
  • Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut BadawczyRecruiting
  • Hospital Universitario Vall DhebronRecruiting
  • Institut Catala DoncologiaRecruiting
  • Hospital Universitario Fundacion Jimenez DiazRecruiting
  • Hospital Universitario Virgen Del RocioRecruiting
  • Churchill Hospital Oxford University Hospital Nhs TrustRecruiting
  • University College HospitalRecruiting
  • Clatterbridge Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Participants will receive BGB-11417

Outcomes

Primary Outcome Measures

Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation.
Part 1: Number of participants experiencing tumor lysis syndrome (TLS) relevant events
Part 2: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)
Defined as the proportion of participants who achieved a complete response (CR), or partial response (PR) per the Lugano Classification

Secondary Outcome Measures

Part 1:Area Under the Plasma Concentration Time Curve (AUC)
Part 1: Maximum Observed Plasma Concentration (Cmax)
Part 1: Time to reach Cmax (Tmax)
Part 1: Steady State Area Under the Plasma Concentration Time Curve (AUC)
Part 1: Steady State Maximum Observed Plasma Concentration (Cmax)
Part 1: Steady State Trough Plasma Concentration (CTrough)
Part 1: Steady State Time to reach Cmax (Tmax)
Part 1: Overall Response Rate (ORR) as assessed by investigator
Defined as the proportion of participants who achieved a complete response (CR), or partial response (PR) per Lugano classification
Duration of Response (DOR) as assessed by investigator (Part 1 and 2) and IRC (Part 2)
DOR is defined as the time from the date of the first documented response (PR or better) after treatment initiation until the date of first documented disease progression or death due to any cause; whichever occurs first
Progression Free Survival (PFS) as assessed by investigator (Part 1 and 2) and IRC (Part 2)
PFS is defined as the time from the date of the first study dose until the date of first documented disease progression or death due to any cause, whichever occurs first.
Time to Response (TTR) as assessed by investigator (Part 1 and 2) and IRC (Part 2)
TTR is defined as the time from start of treatment to first documentation of response of Partial Response (PR) or better
Overall Survival (OS)
defined as time from the start of treatment to the date of death due to any cause
Part 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation.
Part 2: Number of participants with clinically significant changes from baseline in vital signs
Vital signs include blood pressure and pulse rate
Part 2: Number of participants with clinically significant changes from baseline in clinical laboratory values
Laboratory values include hematology, and clinical chemistry
Number of Participants With Clinically Significant Physical Examination Findings
A Physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems
Participant Reported Outcomes as measured by NFLymSI-18
The National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index-18 (FLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score.
Participants Reported Outcome as measured by EQ-5D-5L questionnaires
The EQ-5D-5L descriptive system assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).

Full Information

First Posted
July 21, 2022
Last Updated
September 20, 2023
Sponsor
BeiGene
search

1. Study Identification

Unique Protocol Identification Number
NCT05471843
Brief Title
Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
Official Title
A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Bcl-2 Inhibitor BGB-11417 in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

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

5. Study Description

Brief Summary
The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma (MCL), Relapsed Mantle Cell Lymphoma
Keywords
Mantle Cell Lymphoma, Lymphoma, MCL, Refractory MCL, Refractory Mantle Cell Lymphoma, Relapsed Mantle Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Participants will receive BGB-11417
Intervention Type
Drug
Intervention Name(s)
BGB-11417
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
Time Frame
Up to 1 Year
Title
Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation.
Time Frame
Up to 5 Years
Title
Part 1: Number of participants experiencing tumor lysis syndrome (TLS) relevant events
Time Frame
Up to 5 Years
Title
Part 2: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)
Description
Defined as the proportion of participants who achieved a complete response (CR), or partial response (PR) per the Lugano Classification
Time Frame
Up to 4 Years
Secondary Outcome Measure Information:
Title
Part 1:Area Under the Plasma Concentration Time Curve (AUC)
Time Frame
Up to 2 Years
Title
Part 1: Maximum Observed Plasma Concentration (Cmax)
Time Frame
Up to 2 Years
Title
Part 1: Time to reach Cmax (Tmax)
Time Frame
Up to 2 Years
Title
Part 1: Steady State Area Under the Plasma Concentration Time Curve (AUC)
Time Frame
Up to 2 Years
Title
Part 1: Steady State Maximum Observed Plasma Concentration (Cmax)
Time Frame
Up to 2 Years
Title
Part 1: Steady State Trough Plasma Concentration (CTrough)
Time Frame
Up to 2 Years
Title
Part 1: Steady State Time to reach Cmax (Tmax)
Time Frame
Up to 2 Years
Title
Part 1: Overall Response Rate (ORR) as assessed by investigator
Description
Defined as the proportion of participants who achieved a complete response (CR), or partial response (PR) per Lugano classification
Time Frame
Up to 4 Years
Title
Duration of Response (DOR) as assessed by investigator (Part 1 and 2) and IRC (Part 2)
Description
DOR is defined as the time from the date of the first documented response (PR or better) after treatment initiation until the date of first documented disease progression or death due to any cause; whichever occurs first
Time Frame
Up to 4 Years
Title
Progression Free Survival (PFS) as assessed by investigator (Part 1 and 2) and IRC (Part 2)
Description
PFS is defined as the time from the date of the first study dose until the date of first documented disease progression or death due to any cause, whichever occurs first.
Time Frame
Up to 4 Years
Title
Time to Response (TTR) as assessed by investigator (Part 1 and 2) and IRC (Part 2)
Description
TTR is defined as the time from start of treatment to first documentation of response of Partial Response (PR) or better
Time Frame
Up to 4 Years
Title
Overall Survival (OS)
Description
defined as time from the start of treatment to the date of death due to any cause
Time Frame
Up to 4 Years
Title
Part 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation.
Time Frame
Up to 4 Years
Title
Part 2: Number of participants with clinically significant changes from baseline in vital signs
Description
Vital signs include blood pressure and pulse rate
Time Frame
Up to 4 Years
Title
Part 2: Number of participants with clinically significant changes from baseline in clinical laboratory values
Description
Laboratory values include hematology, and clinical chemistry
Time Frame
Up to 4 Years
Title
Number of Participants With Clinically Significant Physical Examination Findings
Description
A Physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems
Time Frame
Up to 4 Years
Title
Participant Reported Outcomes as measured by NFLymSI-18
Description
The National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index-18 (FLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score.
Time Frame
Up to 4 Years
Title
Participants Reported Outcome as measured by EQ-5D-5L questionnaires
Description
The EQ-5D-5L descriptive system assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
Time Frame
Up to 4 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Histologically confirmed diagnosis of MCL Prior systemic treatments for MCL (at least one line of anti-cluster of differentiate 20 (CD20) based immune or chemoimmunotherapy and at least one line of treatment with Bruton Tyrosine Kinase Inhibitor (BTKi) as mono- or combination therapy) relapsed/refractory disease Presence of measurable disease Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2. Adequate organ function Key Exclusion Criteria: Known central nervous system involvement by lymphoma Prior malignancy other than MCL within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer. Prior exposure to a Bcl-2 inhibitor (eg, venetoclax/ABT-199). Prior autologous stem cell transplant within the last 3 months; or prior chimeric cell therapy within the last 3 months; or prior allogeneic stem cell transplant within the last 6 months or currently has an active graft-vs-host disease requiring the use of immunosuppressants. Clinically significant cardiovascular disease. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment. Active fungal, bacterial or viral infection requiring systemic treatment. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BeiGene
Phone
1.877.828.5568
Email
clinicaltrials@beigene.com
Facility Information:
Facility Name
University of Alabama At Birmingham Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
Des Moines Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Individual Site Status
Recruiting
Facility Name
Tulane Cancer Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Name
Maryland Oncology Hematology, Pa
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Individual Site Status
Recruiting
Facility Name
Nebraska Cancer Specialists
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Individual Site Status
Recruiting
Facility Name
Dartmouth Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Novant Health Hematology Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas Md Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital Erasto Gaertner
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Mae de Deus
City
Porto Alegre
ZIP/Postal Code
90110-270
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
City
Ribeirao Preto
ZIP/Postal Code
14051-140
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sao Rafael (Rede Dor)
City
Salvador
ZIP/Postal Code
41253-190
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Dor de Pesquisa E Ensino Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01401-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
City
Sao Paulo
ZIP/Postal Code
05402-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230088
Country
China
Individual Site Status
Recruiting
Facility Name
China Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Friendship Hospital, Capital Medical University(Tongzhou)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101100
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Name
Guangdong Provincial Peoples Hospital Huifu Branch
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangmen Central Hospital
City
Jiangmen
State/Province
Guangdong
ZIP/Postal Code
529030
Country
China
Individual Site Status
Recruiting
Facility Name
The Tumor Hospital Affiliated to Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Name
Cancer Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550000
Country
China
Individual Site Status
Recruiting
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570206
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
201203
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Nanchang University Branch Donghu
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangxi Province Cancer Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Recruiting
Facility Name
Liaoning Cancer Hospital and Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Individual Site Status
Recruiting
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Qingdao University Branch West Coast
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266555
Country
China
Individual Site Status
Recruiting
Facility Name
Shanxi Provincial Cancer Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030013
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Institute of Hematology and Hospital of Blood Disease
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
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 Name
The First Peoples Hospital of Kashgar
City
Kashgar
State/Province
Xinjiang
ZIP/Postal Code
844099
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Cancer Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Le Mans
City
Le Mans
ZIP/Postal Code
72037
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Nantes Hotel Dieu
City
Nantes Cedex
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Pitie Salpetriere Service Hematologie
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
Necker University Hospital
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Hopital Lyon Sud
City
PierreBenite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Tours Hopital Bretonneau Service Pneumologie
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Koln, Innere Medizin I
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Assuta Ashdod Medical Center
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Individual Site Status
Recruiting
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah En Karem Medical Center
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Centre
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sheba Medical Center
City
Tel Aviv
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Aou Maggiore Della Carita
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Recruiting
Facility Name
Pratia McM Krakow
City
Krakow
ZIP/Postal Code
30-727
Country
Poland
Individual Site Status
Recruiting
Facility Name
Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-034
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall Dhebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Catala Doncologia
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Churchill Hospital Oxford University Hospital Nhs Trust
City
Headington
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Clatterbridge Cancer Centre
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma

We'll reach out to this number within 24 hrs