Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL/SLL (NCT07321652)

🧪 Interventions in This Study

• Zanubrutinib (DRUG)
• Sonrotoclax (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. 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 should be redirected if needed to get first pull bone marrow aspirate. It should be obtained as soon after pre-registration as possible to confirm registration eligibility
2. STEP 0: Patients must be diagnosed with CLL/SLL according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria that includes all of the following:
3. ≥ 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)
4. On morphologic review, the leukemic cells must be small mature lymphocytes
5. Immunophenotype of CLL cells (performed locally) must reveal a clonal B-cell population, which coexpress the B cell surface markers of CD19 and CD20, as well as the T-cell antigen CD5. Patients with bright surface immunoglobulin expression or lack of CD23 expression in \> 10% of cells must lack t(11;14) translocation by interphase cytogenetics
6. STEP 0: Patients must meet criteria for treatment as defined by IWCLL 2018 guidelines which includes at least one of the following criteria:
7. Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia), typically hemoglobin (Hb) \< 10 g/dL, platelet count \< 100,000/mm\^3
8. Massive (\> 6 cm below the costal margin), progressive or symptomatic splenomegaly
9. Massive nodes (ie, \> 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
10. Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy
11. Constitutional symptoms, which include any of the following:
12. Unintentional weight loss of ≥ 10% within the previous 6 months

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (182 Sites)

Showing the first 25 of 182 sites.

• Cedars-Sinai Medical Center — Los Angeles, California
• Kaiser Permanente - Panorama City — Panorama City, California
• Jupiter Medical Center — Jupiter, Florida
• Mount Sinai Medical Center — Miami Beach, Florida
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho
• Saint Alphonsus Cancer Care Center-Caldwell — Caldwell, Idaho
• Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho
• Idaho Urologic Institute-Meridian — Meridian, Idaho
• Saint Alphonsus Cancer Care Center-Nampa — Nampa, Idaho
• Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho
• Kootenai Clinic Cancer Services - Sandpoint — Sandpoint, Idaho
• Illinois CancerCare-Bloomington — Bloomington, Illinois
• Illinois CancerCare-Canton — Canton, Illinois
• Illinois CancerCare-Carthage — Carthage, Illinois
• Northwestern University — Chicago, Illinois
• University of Illinois — Chicago, Illinois
• Carle at The Riverfront — Danville, Illinois
• Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois
• Decatur Memorial Hospital — Decatur, Illinois
• Illinois CancerCare-Dixon — Dixon, Illinois
• Carle Physician Group-Effingham — Effingham, Illinois
• Illinois CancerCare-Eureka — Eureka, Illinois
• Illinois CancerCare-Galesburg — Galesburg, Illinois
• Illinois CancerCare-Kewanee Clinic — Kewanee, Illinois
• Illinois CancerCare-Macomb — Macomb, Illinois

📞 Contact the Study Coordinator

Phone: (773) 702-9171

Email: leukemiaprotocols@alliancenctn.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Chronic Lymphocytic Leukemia

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• Hematopoiesis in MBL and CLL Versus Healthy Age-Matched Control Subjects — Rochester, Minnesota
• A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma — Mobile, Alabama
• Acalabrutinib and Obinutuzumab for the Treatment of Chronic Lymphocytic Leukemia — Houston, Texas
• Pirtobrutinib and Venetoclax With MRD Detection for Previously Untreated Chronic Lymphocytic Leukemia — Rochester, Minnesota

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.