The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05828589
Recruitment Status : Recruiting
First Posted : April 25, 2023
Last Update Posted : March 15, 2024
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study is testing the safety and tolerability of BGB-21447 monotherapy in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study aims to determine the maximum tolerated dose (MTD), maximum adminstered dose (MAD), recommended Phase 2 dose (RP2D), and pharmacokinetic profile of the drug. Additionally, preliminary antitumor activity will be characterized. The study is divided into 2 main parts: Part 1 "Monotherapy Dose Finding" and Part 2 "Monotherapy Dose Expansion."

Condition or disease Intervention/treatment Phase
Relapsed Non-Hodgkin Lymphoma Refractory Non-Hodgkin Lymphoma Relapsed Chronic Lymphocytic Leukemia Refractory Chronic Lymphocytic Leukemia Relapsed Follicular Lymphoma Relapsed Marginal Zone Lymphoma Relapse Diffuse Large B Cell Lymphoma Relapsed Small Lymphocytic Lymphoma Refractory Follicular Lymphoma Refractory Marginal Zone Lymphoma Refractory Small Lymphocytic Lymphoma Richter Transformation Refractory Diffuse Large B-cell Lymphoma Transformed Non-Hodgkin Lymphoma Drug: BGB-21447 Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/1b Open-Label Dose-Escalation Study of Bcl-2 Inhibitor BGB-21447 in Patients With Mature B-Cell Malignancies
Actual Study Start Date : June 20, 2023
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Part 1 (Cohort A1): Dose escalation in patients with B-cell non-Hodgkin lymphoma (NHL)
Participants with R/R B-cell NHL (including diffuse large B-cell lymphoma [DLBCL], follicular lymphoma [FL], marginal zone lymphoma [MZL], transformed B-cell NHL (B-NHL), and Richter's transformation to DLBCL) will receive BGB-21447 once a day.
 Drug: BGB-21447
BGB-21447 will be administered orally
Experimental: Part 1 (Cohort B): Dose escalation in R/R CLL/SLL participants with low tumor burden
Participants with relapsed/refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) will receive BGB-21447 once a day.
 Drug: BGB-21447
BGB-21447 will be administered orally
Experimental: Part 2 (Cohort A2): BGB-21447 Monotherapy Dose Expansion
Participants will receive BGB-21447 with up to two dose levels from Cohort A1 for further evaluation of safety and efficacy.
 Drug: BGB-21447
BGB-21447 will be administered orally


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Part 1: Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Up to approximately four years ]
    Number of participants with dose limiting toxicities, defined as [see text in SAP or protocol for specific definition]

  2. Number of participants with adverse events (AEs) [ Time Frame: Up to approximately four years ]
    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) assessed and graded based upon the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).

  3. Number of participants with Tumor Lysis Syndrome (TLS) [ Time Frame: Up to approximately four years ]

    TLS will be determined via laboratory values and assessed by the investigator.

    In laboratory tumor lysis syndrome, 2 or more metabolic abnormalities must be present during the 24-hour period within 3 days before the start of study drug treatment or up to 7 days afterward. Clinical tumor lysis syndrome requires the presence of laboratory tumor lysis syndrome plus an increased creatinine level, seizures, cardiac dysrhythmia, or death.



Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of BGB-21447 [ Time Frame: Up to approximately four years ]
  2. Pre-dose trough concentration (Ctrough) of BGB-21447 [ Time Frame: Up to approximately four years ]
  3. Area under the curve from time 0 to the last sampling time point within the dose interval (AUClast) of BGB-21447 [ Time Frame: Up to approximately four years ]
  4. Area under the curve from time 0 extrapolated to infinity (AUCinf) of BGB-21447 [ Time Frame: Up to approximately four years ]
  5. Time to reach maximum observed plasma concentration (Tmax) of BGB-21447 [ Time Frame: Up to approximately four years ]
  6. Apparent terminal elimination half life (t1/2) of BGB-21447 [ Time Frame: Up to approximately four years ]
  7. Apparent oral clearance (CL/F) of BGB-21447 [ Time Frame: Up to approximately four years ]
  8. Apparent volume of distribution (Vz/F) of BGB-21447 [ Time Frame: Up to approximately four years ]
  9. Steady state maximum observed plasma concentration (Cmax) of BGB-21447 [ Time Frame: Up to approximately four years ]
  10. Steady state pre-dose trough concentration (Ctrough) of BGB-21447 [ Time Frame: Up to approximately four years ]
  11. Steady state area under the curve from time 0 to the last sampling time point within the dose interval (AUClast) of *drug name* [ Time Frame: Up to approximately four years ]
  12. Steady state area under the curve from time 0 extrapolated to infinity (AUCinf) of BGB-21447 [ Time Frame: Up to approximately four years ]
  13. Steady state time to reach maximum observed plasma concentration (Tmax) of BGB-21447 [ Time Frame: Up to approximately four years ]
  14. Steady state apparent terminal elimination half life (t1/2) of BGB-21447 [ Time Frame: Up to approximately four years ]
  15. Steady state apparent oral clearance (CL/F) of BGB-21447 [ Time Frame: Up to approximately four years ]
  16. Steady state apparent volume of distribution (Vz/F) of BGB-21447 [ Time Frame: Up to approximately four years ]
  17. Overall response rate (ORR) [ Time Frame: Up to approximately four years ]
    defined as the percentage of patients who achieve partial response or better for diffuse large B-cell lymphoma, marginal zone lymphoma, follicular lymphoma, transformed B-NHL, and Richter's transformation to DLBCL as per the Lugano Classification for non-Hodgkin lymphoma

  18. Duration of Response (DOR) [ Time Frame: Up to approximately four years ]
    defined as the time from the first response documentation to the date that progression is documented after treatment initiation or death due to any cause, whichever occurs first.

  19. Time to response (TTR) [ Time Frame: Up to approximately four years ]
    defined as the time from treatment initiation to the first documentation of response.

  20. Progression-free survival (PFS) [ Time Frame: Up to approximately four years ]
    defined as the time from treatment initiation to the first documented disease progression or death due to any cause, whichever occurs first.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise noted) of one of the following:

    Cohort A1 and Cohort A2:

    1. R/R DLBCL
    2. R/R FL
    3. R/R MZL
    4. Transformed B-cell NHL
    5. Richter's transformation to DLBCL
  2. Measurable disease by computed tomography/magnetic resonance imaging.

Exclusion Criteria:

  1. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer
  2. Known central nervous system involvement by lymphoma/leukemia
  3. Prior autologous stem cell transplant < 3 months before the first dose of study drug. Or prior chimeric antigen receptor T-cell (CAR-T) therapy < 3 months before the first dose of study drug
  4. Prior allogeneic stem cell transplant.
  5. Major surgery < 4 weeks before the first dose of study treatment

NOTE: Other Inclusion/Exclusion criteria may apply.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05828589


Contacts
Layout table for location contacts
Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com

Locations
Layout table for location information
Australia, Western Australia
Linear Clinical Research Recruiting
Nedlands, Western Australia, Australia, 6009
China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100000
China, Fujian
Fujian Cancer Hospital Recruiting
Fuzhou, Fujian, China, 350014
China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450000
China, Hubei
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
China, Jiangsu
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China, 210029
The First Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215006
China, Jiangxi
The First Affiliated Hospital of Nanchang University Branch Donghu Recruiting
Nanchang, Jiangxi, China, 330006
China, Liaoning
Shengjing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110004
China, Shandong
Shandong Provincial Hospital Recruiting
Jinan, Shandong, China, 250021
Linyi Peoples Hospital Recruiting
Linyi, Shandong, China, 276000
China, Shanghai
Affiliated Zhongshan Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 200032
China, Tianjin
Institute of Hematology and Hospital of Blood Disease Recruiting
Tianjin, Tianjin, China, 300020
China, Zhejiang
The First Affiliated Hospital, Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
BeiGene
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT05828589    
Other Study ID Numbers: BGB-21447-101
CT-2023-CTN-05421-1 ( Other Identifier: Australia Clinical Trial Number )
First Posted: April 25, 2023    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeiGene:
Relapsed Non-Hodgkin Lymphoma
refractory non-Hodgkin lymphoma
Relapsed Chronic Lymphocytic Leukemia
Follicular Lymphoma
Marginal Zone Lymphoma
NHL
FL
MZL
Refractory Chronic Lymphocytic Leukemia
RCLL
Relapsed Follicular Lymphoma
 Refractory Follicular Lymphoma
Relapsed Marginal Zone Lymphoma
Refractory Marginal Zone Lymphoma
RFL
RMZL
Relapsed Small Lymphocytic Lymphoma
Refractory Small Lymphocytic Lymphoma
RSLL
Richter's transformation
RT
RR DLBCL
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Leukemia
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Leukemia, B-Cell
Chronic Disease
Disease Attributes
Pathologic Processes