Sonrotoclax and Zanubrutinib for Untreated CLL/SLL

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

Recruiting Phase 3 Interventional Study
Chronic Lymphocytic Leukemia Small Lymphocytic Leukemia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
65 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
466 (estimated)
Sponsor
Alliance for Clinical Trials in Oncology · Other
Who this trial is looking for

This trial is looking for patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Participants will receive a combination of sonrotoclax and zanubrutinib to see if it works better than zanubrutinib alone.

Are You a Good Fit for This Trial?
Must not be taking Warfarin
Rules you out Active cardiac diseaseSevere bleeding disorderCentral nervous system disease

You may be able to join if

  • I have been diagnosed with CLL or SLL.
  • I am at least 65 years old.
  • I have signs of needing treatment.
  • I have measurable and trackable B cell clones.
  • I have an ECOG performance status of 2 or lower.
  • I have not received prior treatment for my CLL/SLL.
  • I have a known HIV infection that is under control.
  • I am not receiving active systemic anticoagulation with warfarin.

You may not be able to join if

  • I have had a heart attack in the past 6 months.
  • I have a severe bleeding disorder.
  • I have active progressive central nervous system disease.
  • I cannot swallow oral medications.
  • I have ongoing active infections requiring systemic therapy.
  • I have uncontrolled systemic infections requiring intravenous antibiotics.
  • I require more than 20 mg of prednisone daily.
  • I have active cardiac disease requiring evaluation.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 su…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * STEP 0: This bone marrow or peripheral blood submission to Adaptive is mandatory prior to registration/randomization for real-time identification of the clone needed for MRD testing. The bone marrow sample should be from the first aspiration (i.e., first pull). Aspirate needle…
Contacts

Jayke Giese

773-702-9171

leukemiaprotocols@alliancenctn.org

CONTACT