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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-20

Study Completion Date

2027-04-30

Brief Summary

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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."

Detailed Description

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Conditions

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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

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL