Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL/SLL

This phase III trial compares the effect of adding sonrotoclax to zanubrutinib versus zanubrutinib alone for the treatment of patients with untreated chronic lymphoblastic leukemia (CLL)/small lymphocytic lymphoma (SLL). Sonrotoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphom

Trial Details

NCT ID
NCT07321652
Phase
PHASE3
Sponsor
Alliance for Clinical Trials in Oncology
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Zanubrutinib
  • Sonrotoclax
  • Computed Tomography
  • Bone Marrow Aspiration
  • Biospecimen Collection
  • Survey Administration
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Anaheim, California, United States|33.83529,-117.9145
  • Baldwin Park, California, United States|34.08529,-117.9609
  • Bellflower, California, United States|33.88168,-118.11701
  • Dublin, California, United States|37.70215,-121.93579

Key Eligibility Criteria

  • STEP 0: This bone marrow or peripheral blood submission to Adaptive is mandatory prior to registration/randomization for real-time identification o…
  • STEP 0: Patients must be diagnosed with CLL/SLL according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria that incl…
  • ≥ 5 x10\^9 /L B lymphocytes (5000/μL) in the peripheral blood (CLL) or a lymph node biopsy demonstrating SLL with the below immunophenotype (SLL)
  • On morphologic review, the leukemic cells must be small mature lymphocytes

For full eligibility, visit ClinicalTrials.gov.

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