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)

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 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.

Official Title

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

Quick Facts

Study Start:2025-06
Study Completion:2032-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06943872

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. * Confirmed diagnosis of CLL/SLL that meets the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
  2. * 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
  3. * Participants with prior BCL2i exposure are eligible if remission duration was ≥3 years with ≥2 years from last BCL2i intake
  4. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
  5. * Adequate organ function
  1. * Known active prolymphocytic leukemia or currently suspected Richter's transformation
  2. * Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
  3. * 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
  4. * Known central nervous system involvement by CLL/SLL
  5. * Severe or debilitating pulmonary disease
  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)

Chao Family Comprehensive Cancer Center
Orange, California, 92868-3201
United States
Stanford Cancer Institute
Palo Alto, California, 94304-2205
United States
Scripps Prebys Cancer Center
San Diego, California, 92103-2106
United States
Rocky Mountain Cancer Centers (Williams) Usor
Aurora, Colorado, 80012-5405
United States
Yale University, Yale Cancer Center
New Haven, Connecticut, 06520-8028
United States
Eastern Connecticut Hematology and Oncology
Norwich, Connecticut, 06360-2700
United States
University of Miami
Miami, Florida, 33136-2107
United States
Northwestern University
Chicago, Illinois, 60611
United States
Illinois Cancer Specialists (Niles) Usor
Niles, Illinois, 60714-5905
United States
Mission Cancer and Blood
Waukee, Iowa, 50263
United States
University of Louisville, Brown Cancer Center
Louisville, Kentucky, 40202
United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809-3738
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
The Cancer and Hematology Centers
Grand Rapids, Michigan, 49503-2563
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905-0001
United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, 10065-6800
United States
Clinical Research Alliance, Inc
Westbury, New York, 11590-5119
United States
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27514-4220
United States
Levine Cancer Center
Charlotte, North Carolina, 28204-2990
United States
Oncology Hematology Care Clinical Trials, Llc
Cincinnati, Ohio, 45245-1995
United States
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, 97401
United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania, 15232-1309
United States
Tennessee Oncology
Nashville, Tennessee, 37205
United States
Texas Oncology Baylorcharles A Sammons Cancer Center
Dallas, Texas, 75246-2003
United States
Ut Southwestern Medical Center
Dallas, Texas, 75390-7208
United States
Texas Oncology San Antonio Medical Center Usor
San Antonio, Texas, 78240-5251
United States
Texas Oncology Tyler
Tyler, Texas, 75702-7522
United States
Northwest Cancer Specialist, Pc(Us Oncology Research)
Vancouver, Washington, 98684-6930
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 Date2025-06
Study Completion Date2032-12-31

Study Record Updates

Study Start Date2025-06
Study Completion Date2032-12-31

Terms related to this study

Keywords Provided by Researchers

  • B-cell lymphoma 2 inhibitor (BCL-2i)
  • CLL-RR1
  • German CLL Study Group

Additional Relevant MeSH Terms

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma