A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia

Description

This study will evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax (BGB-11417) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult participants with previously untreated WM.

Conditions

Waldenstrom Macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory

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Study Overview

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Study Details

Study overview

This study will evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax (BGB-11417) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult participants with previously untreated WM.

An Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of the BCL2 Inhibitor Sonrotoclax (BGB-11417) as Monotherapy and in Combination With Zanubrutinib (BGB-3111) in Patients With Waldenström Macroglobulinemia

A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia

Condition
Waldenstrom Macroglobulinemia
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope National Medical Center, Duarte, California, United States, 91010

Denver

Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

Washington

Medstar Georgetown University Hospital, Washington, District of Columbia, United States, 20007

Miami

University of Miami, Miami, Florida, United States, 33136

Warrenville

Northwestern Medicine Cancer Center, Warrenville, Illinois, United States, 60555

Des Moines

Mission Cancer and Blood, Des Moines, Iowa, United States, 50309

Baltimore

University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States, 21201

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Rochester

Mayo Clinic Rochester, Rochester, Minnesota, United States, 55905

Hattiesburg

Hattiesburg Hematology and Oncology Clinic, Hattiesburg, Mississippi, United States, 39401

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Clinical and definitive histologic diagnosis of WM.
  • * Meeting ≥ 1 criterion for treatment according to consensus panel criteria from the 2nd International Workshop on Waldenström's Macroglobulinemia (IWWM).
  • * For Cohorts 1-3, refractory or relapsed disease at study entry unless participants had intolerance to the most recent therapy. Refractory disease is defined as not attaining at least a major response, or progressing while on or within 6 months of completing therapy. Relapsed disease is defined as attaining at least a major response to therapy and meeting the criteria for disease progression beyond 6 months after completing therapy.
  • * For Cohort 4, patients must not have received prior therapy for WM (except for plasmapheresis).
  • * Adequate organ function.
  • * Central nervous system (CNS) involvement by WM.
  • * Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma.
  • * History of other malignancies ≤ 2 years before study entry.
  • * Uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed ≤ 14 days before the first dose of the study drug.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BeiGene,

Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

2028-09