ACTIVE_NOT_RECRUITING

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

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Conditions

Waldenstrom MacroglobulinemiaWaldenstrom's Macroglobulinemia RecurrentWaldenstrom's Macroglobulinemia RefractoryWaldenström's macroglobulinemiaLymphomaBGB-11417BCL-2i

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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 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.

Official Title

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

Quick Facts

Study Start:2023-09-28
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05952037

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. * Clinical and definitive histologic diagnosis of WM.
  2. * Meeting ≥ 1 criterion for treatment according to consensus panel criteria from the 2nd International Workshop on Waldenström's Macroglobulinemia (IWWM).
  3. * 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.
  4. * For Cohort 4, patients must not have received prior therapy for WM (except for plasmapheresis).
  5. * Adequate organ function.
  1. * Central nervous system (CNS) involvement by WM.
  2. * Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma.
  3. * History of other malignancies ≤ 2 years before study entry.
  4. * Uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed ≤ 14 days before the first dose of the study drug.

Contacts and Locations

Principal Investigator

Study Director
STUDY_DIRECTOR
BeOne Medicines

Study Locations (Sites)

City of Hope National Medical Center
Duarte, California, 91010-3012
United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218
United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007-2113
United States
University of Miami
Miami, Florida, 33136-2107
United States
Northwestern Medicine Cancer Center
Warrenville, Illinois, 60555-3269
United States
Mission Cancer and Blood
Waukee, Iowa, 50263
United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201-1544
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215-5418
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905-0001
United States
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, 39401-7233
United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, 10065-6800
United States
Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina, 28204-2990
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1280
United States
Ut Southwestern Medical Center
Dallas, Texas, 75390-7208
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
United States
University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: BeOne Medicines

  • Study Director, STUDY_DIRECTOR, BeOne Medicines

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 Date2023-09-28
Study Completion Date2028-08

Study Record Updates

Study Start Date2023-09-28
Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

  • Waldenström's macroglobulinemia
  • Waldenstrom's Macroglobulinemia Recurrent
  • Waldenstrom's Macroglobulinemia Refractory
  • Lymphoma
  • BGB-11417
  • BCL-2i

Additional Relevant MeSH Terms

  • Waldenstrom Macroglobulinemia
  • Waldenstrom's Macroglobulinemia Recurrent
  • Waldenstrom's Macroglobulinemia Refractory