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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 Optimization."

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 : 112 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-06-20
Estimated Primary Completion Date : 2027-04
Estimated Study Completion Date : 2027-04

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 (for Cohort A1 and Cohort A2.1)
    • * High-grade B-cell lymphomas with translocations of MYC and Bcl-2 and/or Bcl-6 are not allowed in Cohort A1 but may be allowed in Cohort A2.1
    • 2. R/R FL (for Cohort A1 and Cohort A2.2)
    • 3. R/R MZL (for Cohort A1 and Cohort A2.2)
    • 4. Transformed B-cell NHL (for Cohort A1 only)
    • 5. Richter's transformation to DLBCL (for Cohort A1 only)
    • 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 or lentigo maligna melanoma that has been curatively resected
    • 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

    University of Iowa Hospitals and Clinics

    Iowa City, Iowa, United States, 52242-1009

    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, New York

    Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health

    New York, New York, United States, 10016-2708

    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

    NOT YET RECRUITING

    China, Hubei

    Yichang Central Peoples Hospitaljiangnan Branch

    Yichang, Hubei, China, 443001

    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

    COMPLETED

    China, Shandong

    Linyi Peoples Hospital

    Linyi, Shandong, China, 276000

    RECRUITING

    China, Shanghai

    Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai, China, 200032

    NOT YET RECRUITING

    China, Sichuan

    West China Hospital, Sichuan University

    Chengdu, Sichuan, China, 610041

    RECRUITING

    China, Tianjin

    Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin, China, 300020

    COMPLETED

    China, Zhejiang

    The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China, 310003

    NOT YET RECRUITING

    France,

    Chu Dijon

    Dijon, France, 21000

    NOT YET RECRUITING

    France,

    CHU Montpellier HOSTAL SAINT ELOI

    Montpellier, France, 34090

    NOT YET RECRUITING

    France,

    Saint Louis hospital

    Paris, France, 75010

    NOT YET RECRUITING

    France,

    Iuc Toulouse Oncopole

    Toulouse, France, 31100

    NOT YET RECRUITING

    Italy,

    Policlinico Santarsola Malpighi University Hospital

    Bologna, Italy, 40138

    NOT YET RECRUITING

    Italy,

    National Cancer Institute of the G Pascale Foundation

    Napoli, Italy, 80131

    NOT YET RECRUITING

    Italy,

    Humanitas Clinical Institute

    Rozzano, Italy, 20089

    NOT YET RECRUITING

    Italy,

    Clinical Centrorche of Verona Srl

    Verona, Italy, 37134

    RECRUITING

    New Zealand,

    Auckland City Hospital

    Auckland, New Zealand, 1023