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

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).

Conditions

CLL, Chronic Lymphocytic Leukemia

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
CLL
Intervention / Treatment

-

Contacts and Locations

Weston

Cleveland Clinic Florida, Weston, Florida, United States, 33331-3609

Atlanta

Emory University Winship Cancer Institute, Atlanta, Georgia, United States, 30322-1013

Baton Rouge

Our Lady of the Lake Hospital, Baton Rouge, Louisiana, United States, 70808-4365

Westbury

Clinical Research Alliance, Inc, Westbury, New York, United States, 11590-5119

Cleveland

University Hospitals, Cleveland, Ohio, United States, 44106-1716

Tyler

Texas Oncology Tyler, Tyler, Texas, United States, 75702-7522

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

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

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

2030-02-14