RECRUITING

A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors

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

The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (idelalisib plus rituximab \[for CLL only\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).

Official Title

A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors

Quick Facts

Study Start:2025-04-10
Study Completion:2030-02-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06846671

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. 1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
  2. 2. Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
  3. 3. Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)
  4. 4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
  5. 5. Adequate liver function
  6. 6. Adequate blood clotting function
  1. 1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
  2. 2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months
  3. 3. Known central nervous system involvement
  4. 4. Prior exposure to any BTK protein degraders
  5. 5. Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy
  6. 6. Clinically significant cardiovascular disease

Contacts and Locations

Study Contact

Study Director
CONTACT
1.877.828.5568
clinicaltrials@beigene.com

Principal Investigator

Study Director
STUDY_DIRECTOR
BeiGene

Study Locations (Sites)

Cleveland Clinic Florida
Weston, Florida, 33331-3609
United States
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322-1013
United States
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, 70808-4365
United States
Clinical Research Alliance, Inc
Westbury, New York, 11590-5119
United States
University Hospitals
Cleveland, Ohio, 44106-1716
United States
Texas Oncology Tyler
Tyler, Texas, 75702-7522
United States

Collaborators and Investigators

Sponsor: BeiGene

  • Study Director, STUDY_DIRECTOR, BeiGene

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 Date2025-04-10
Study Completion Date2030-02-14

Study Record Updates

Study Start Date2025-04-10
Study Completion Date2030-02-14

Terms related to this study

Keywords Provided by Researchers

  • CLL

Additional Relevant MeSH Terms

  • CLL
  • Chronic Lymphocytic Leukemia