Comparing sonrotoclax combinations versus venetoclax plus rituximab for relapsed or refractory CLL/SLL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 3 trial compares two sonrotoclax-containing regimens (sonrotoclax plus obinutuzumab and sonrotoclax plus rituximab) against the established venetoclax plus rituximab regimen in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. The primary outcome is progression-free survival, and the study will also monitor safety and tolerability of the combinations. Eligible participants must meet iwCLL diagnostic criteria, have had at least one prior therapy, and have ECOG performance status 0–2 with adequate organ function; limited prior BCL-2 inhibitor exposure is permitted under specific timing and remission conditions. Treatments are administered at specialized cancer centers with scheduled clinical and laboratory follow-up.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

* 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.

Where it's running

• Uci Health Laguna Hills
  Laguna Hills, California, United States Recruiting
• Chao Family Comprehensive Cancer Center
  Orange, California, United States Recruiting
• Stanford Cancer Institute
  Palo Alto, California, United States Recruiting
• Scripps Prebys Cancer Center
  San Diego, California, United States Recruiting
• Rocky Mountain Cancer Centers (Williams) Usor
  Aurora, Colorado, United States Recruiting
• Yale University Yale Cancer Center
  New Haven, Connecticut, United States Recruiting

+145 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 1-877-828-5568

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL

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• Venetoclax plus obinutuzumab followed by epcoritamab for untreated CLL/SLL

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  Recruiting at 4 sites Phase 2 City of Hope Medical Center · Duarte, California and 6 other locations · NCT07218510

• Epcoritamab given after 2nd-generation BTK inhibitors for CLL/SLL

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• LP-168 plus obinutuzumab for previously treated and BTK T474I‑mutated CLL/SLL

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• Combination treatment for chronic lymphocytic leukemia and lymphoma

  This study is testing a new combination treatment with sonrotoclax and either zanubrutinib or rituximab to see if it can help patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and mantle cell lymphoma.

  Recruiting Phase 2 Fred Hutchinson Cancer Center · Seattle, Washington · NCT06839053

• Combining zanubrutinib and obinutuzumab for untreated chronic lymphocytic leukemia or small lymphocytic lymphoma

  This study is testing if combining two medications, zanubrutinib and obinutuzumab, can help people with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma achieve better treatment results.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.