RECRUITING

A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)

Description

The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.

Conditions

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
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Related Conditions:

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Study Overview

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Study Details

Study overview

The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.

A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)

Condition
Chronic Lymphocytic Leukemia
Intervention / Treatment

-

Contacts and Locations

Orange

Chao Family Comprehensive Cancer Center, Orange, California, United States, 92868-3201

Palo Alto

Stanford Cancer Institute, Palo Alto, California, United States, 94304-2205

San Diego

Scripps Prebys Cancer Center, San Diego, California, United States, 92103-2106

Aurora

Rocky Mountain Cancer Centers (Williams) Usor, Aurora, Colorado, United States, 80012-5405

New Haven

Yale University, Yale Cancer Center, New Haven, Connecticut, United States, 06520-8028

Norwich

Eastern Connecticut Hematology and Oncology, Norwich, Connecticut, United States, 06360-2700

Miami

University of Miami, Miami, Florida, United States, 33136-2107

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Niles

Illinois Cancer Specialists (Niles) Usor, Niles, Illinois, United States, 60714-5905

Waukee

Mission Cancer and Blood, Waukee, Iowa, United States, 50263

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

  • * Confirmed diagnosis of CLL/SLL that meets the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
  • * Received one or more prior therapies for CLL/SLL. For each line of therapy, participants must have received at least 2 cycles of the therapy
  • * Participants with prior BCL2i exposure are eligible if remission duration was ≥3 years with ≥2 years from last BCL2i intake
  • * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
  • * Adequate organ function
  • * Known active prolymphocytic leukemia or currently suspected Richter's transformation
  • * Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
  • * Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent
  • * Known central nervous system involvement by CLL/SLL
  • * Severe or debilitating pulmonary disease
  • * 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

2032-12-31