ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 administered 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 Optimization."

Official Title

A Phase 1/1b Open-Label Dose-Escalation and Dose-Optimization Study of Bcl-2 Inhibitor BGB-21447 in Patients With Mature B-Cell Malignancies

Quick Facts

Study Start:2023-06-20
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05828589

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 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 or lentigo maligna melanoma that has been curatively resected
  2. 2. Known central nervous system involvement by lymphoma/leukemia
  3. 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. 4. Prior allogeneic stem cell transplant.
  5. 5. Major surgery \< 4 weeks before the first dose of study treatment

Contacts and Locations

Principal Investigator

Study Director
STUDY_DIRECTOR
BeiGene

Study Locations (Sites)

Sibley Memorial Hospital Johns Hopkins Medicine
Washington D.C., District of Columbia, 20016
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1009
United States
Mission Cancer and Blood
Waukee, Iowa, 50263
United States
Sidney Kimmel Comprehensive Cancer At Johns Hopkins
Baltimore, Maryland, 21287
United States
Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island
Mineola, New York, 11501
United States
Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health
New York, New York, 10016-2708
United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105-2108
United States

Collaborators and Investigators

Sponsor: BeiGene

  • Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-20
Study Completion Date2027-04

Study Record Updates

Study Start Date2023-06-20
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • 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
  • Bcl-2
  • Bcl-2i

Additional Relevant MeSH Terms

  • 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