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NCT05828589 | RECRUITING | Relapsed Non-Hodgkin Lymphoma

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

Beigene

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 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 Expansion."

Condition or disease

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

Judge transformation

Refractory Diffuse Large B-cell Lymphoma

Transformed Non-Hodgkin Lymphoma

Intervention/treatment

BGB-21447

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 85 participants
Masking : NONE
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 : 2023-06-20
Estimated Primary Completion Date : 2026-03
Estimated Study Completion Date : 2026-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 protocol-defined Inclusion/Exclusion criteria may apply.
    • A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies

    Location Details

    NCT05828589

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    NOT YET RECRUITING

    United States, Iowa

    Mission Cancer and Blood

    Waukee, Iowa, United States, 50263

    NOT YET RECRUITING

    United States, Maryland

    Sidney Kimmel Comprehensive Cancer At Johns Hopkins

    Baltimore, Maryland, United States, 21287

    NOT YET RECRUITING

    United States, Pennsylvania

    Thomas Jefferson University

    Philadelphia, Pennsylvania, United States, 19107-4216

    NOT YET RECRUITING

    United States, South Dakota

    Avera Cancer Institute

    Sioux Falls, South Dakota, United States, 57105-2108

    RECRUITING

    Australia, New South Wales

    Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, Australia, 2148

    RECRUITING

    Australia, Queensland

    Pindara Private Hospital

    Benowa, Queensland, Australia, 4217

    RECRUITING

    Australia, Victoria

    Monash Health

    Clayton, Victoria, Australia, 3168

    RECRUITING

    Australia, Western Australia

    Linear Clinical Research

    Nedlands, Western Australia, Australia, 6009

    RECRUITING

    China, Beijing

    Peking University Third Hospital

    Beijing, Beijing, China, 100000

    RECRUITING

    China, Fujian

    Fujian Cancer Hospital

    F U-axis, Fujian, China, 350014

    RECRUITING

    China, Henan

    Henan Cancer Hospital

    Zhengzhou, Henan, China, 450000

    RECRUITING

    China, Hubei

    Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, China, 430030

    RECRUITING

    China, Jiangsu

    Jiangsu Province Hospital

    Nanjing, Jiangsu, China, 210029

    RECRUITING

    China, Jiangsu

    The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, China, 215006

    RECRUITING

    China, Jiangxi

    The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, China, 330006

    RECRUITING

    China, Jiangxi

    The First Affiliated Hospital of Nanchang University Branch Xianghu

    Nanchang, Jiangxi, China, 332000

    RECRUITING

    China, Liaoning

    Shengjing Hospital of China Medical University

    Shenyang, Liaoning, China, 110004

    RECRUITING

    China, Shandong

    Shandong Provincial Hospital

    Women, Shandong, China, 250021

    RECRUITING

    China, Shandong

    Linyi Peoples Hospital

    Linyi, Shandong, China, 276000

    RECRUITING

    China, Shanghai

    Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai, China, 200032

    RECRUITING

    China, Tianjin

    Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin, China, 300020

    RECRUITING

    New Zealand,

    Auckland City Hospital

    Auckland, New Zealand, 1023