Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around

Description

Summary

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

Details

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Keywords

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, B-cell lymphoma 2 inhibitor (BCL-2i), CLL-RR1, German CLL Study Group, Leukemia, Lymphocytic, Chronic, B-Cell, obinutuzumab, Rituximab, venetoclax, Sonrotoclax, Sonrotoclax plus Obinutuzumab, Sonrotoclax plus Rituximab, Sonrotoclax plus Obinutuzumab (MRD), Venetoclax plus Rituximab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • Uci Health Laguna Hills accepting new patients
    Laguna Hills California 92653 United States
  • Scripps Prebys Cancer Center accepting new patients
    San Diego California 92103-2106 United States
  • Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868-3201 United States
  • Stanford Cancer Institute accepting new patients
    Palo Alto California 94304-2205 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BeOne Medicines
ID
NCT06943872
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 630 study participants
Last Updated