Adding a targeted cancer drug to standard therapy for untreated CLL/SLL
Official title: Phase III Evaluation of Fixed Duration Zanubrutinib Plus Sonrotoclax-Based Therapy Compared to Continuous Zanubrutinib in Previously Untreated Older Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Run by Alliance for Clinical Trials in Oncology · NCT07321652 · Data updated 2026-11-12
This trial tests whether adding sonrotoclax to zanubrutinib helps people with untreated CLL/SLL live longer without the disease getting worse.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 466 (estimated) |
| Sponsor | Alliance for Clinical Trials in Oncology Academic / other |
| Drugs / interventions | rituximab, zanubrutinib, prednisone |
| Locations | 261 sites (Birmingham, Alabama and 260 other locations) |
| Status | Recruiting |
| Started | April 30, 2026 |
| Main results expected | September 30, 2028 |
| Study ends | September 30, 2038 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07321652 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with previously untreated CLL/SLL who meet MRD testing requirements and eligibility criteria at participating centers.
✕Probably not a fit
Patients unlikely to benefit include those with contraindications to either drug, or disease characteristics that may not respond to these agents.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 3 study compares two treatment strategies for previously untreated CLL/SLL: zanubrutinib alone versus zanubrutinib plus sonrotoclax. The trial includes MRD-guided and fixed-duration approaches to combination therapy, with progression-free survival as a primary endpoint. Secondary goals include overall survival, MRD dynamics, response rates, time to next therapy, and safety with attention to infections, cardiovascular events, cytopenias, and secondary cancers. Eligible participants undergo MRD testing and require pre-registration bone marrow or peripheral blood samples for real-time MRD assessment. The study is sponsored by the Alliance for Clinical Trials in Oncology, with NCI collaboration, at multiple U.S. sites.
Why it matters
Potential benefit: If successful, adding sonrotoclax could improve disease control and potentially extend time before needing additional treatment.
How similar studies have gone: Prior research in BCL-2 inhibitors and BTK inhibitors has shown activity in CLL/SLL, supporting exploration of this combination in untreated disease.
Who can join: the full rules
Show full inclusion / exclusion 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 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
* 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:
* ≥ 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
* 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
* STEP 0: Patients must meet criteria for treatment as defined by IWCLL 2018 guidelines which includes at least one of the following criteria:
* 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
* Massive (\> 6 cm below the costal margin), progressive or symptomatic splenomegaly
* Massive nodes (ie, \> 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
* Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy
* Constitutional symptoms, which include any of the following:
* Unintentional weight loss of ≥ 10% within the previous 6 months
* Significant fatigue (ie. Eastern Cooperative Oncology Group \[ECOG\] performance status \[PS\] ≥ 2)
* Fevers \>100.5 °F or 38.0°C for 2 weeks or more without evidence of infection
* Night sweats \> 1 month without evidence of infection
* STEP 0: Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids)
* STEP 0: Treatment with rituximab and/or high-dose corticosteroids for autoimmune complications of CLL must be completed prior to enrollment. Palliative steroids must be at a dose not higher than 20 mg/day of prednisone or equivalent corticosteroid at the time of registration
* STEP 0: Age ≥ 65 years
* STEP 0: ECOG performance status ≤ 2
* STEP 0: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
* STEP 0: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* STEP 0: Patients with a history of hepatitis C virus (HCV), infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* STEP 0: Patients must not be receiving active systemic anticoagulation with warfarin. Patients must be off warfarin therapy for at least 5 half-lives washout and with normal INR prior to enrollment
* STEP 0: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients must be class 2B or better.
Patients with acute cardiac events within 6 months prior to registration should be carefully evaluated for their suitability for enrollment
* STEP 0: No patients with a history of a severe bleeding disorder or a history of hemorrhagic stroke or intracranial hemorrhage
* STEP 0: No patients with known active progressive central nervous system (CNS) disease
* STEP 0: No known medical condition causing an inability to swallow oral formulations of agents
* STEP 1: The adaptive report confirming a measurable and trackable B cell clone
* STEP 1: Patients may not have had major surgery within 7 days of enrollment, or minor surgery within 5 days of enrollment. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. The decision about whether a surgery is major or minor can be made at the discretion of the treating physician
* STEP 1: No patients with ongoing active fungal, bacterial or viral infection requiring systemic therapy except those described in the protocol document
* STEP 1: Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily
* STEP 1: Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics
* STEP 1: Patients must not have continued requirement for therapy with a strong CYP3A4/5 inhibitor or inducer. Any such inhibitor or inducer must have been discontinued at least 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug
* STEP 1: Absolute neutrophil count (ANC) ≥ 1,000/mm3 unless due to marrow involvement
* STEP 1: Platelet count ≥ 30,000/mm3
* STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless due to liver involvement, hemolysis or Gilbert's disease)
* STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3.0 x upper limit of normal (ULN) unless due to disease infiltration of the liver
* STEP 1: Calculated (calc.) creatinine clearance by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) ≥ 30 mL/min
* STEP 1: Urine protein to creatinine ratio \< 1 or urine protein ≤ 1+
* STEP 2: Detectable MRD ≥ 10 residual clonal cells per million nucleated cells in peripheral blood at the C15 restaging evaluation from ClonoSEQ
* STEP 2: Response of PR, PR-L, CR, CCR or CRi to zanubrutinib sonrotoclax therapy
Where it's running
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States Recruiting -
Kaiser Permanente-Anaheim
Anaheim, California, United States Recruiting -
Kaiser Permanente-Baldwin Park
Baldwin Park, California, United States Recruiting -
Kaiser Permanente-Bellflower
Bellflower, California, United States Recruiting -
Kaiser Permanente Dublin
Dublin, California, United States Recruiting -
Kaiser Permanente-Fontana
Fontana, California, United States Recruiting
Show 44 more locations
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Kaiser Permanente-Fremont
Fremont, California, United States Recruiting -
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, United States Recruiting -
Kaiser Permanente South Bay
Harbor City, California, United States Recruiting -
Kaiser Permanente-Irvine
Irvine, California, United States Recruiting -
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States Recruiting -
Kaiser Permanente West Los Angeles
Los Angeles, California, United States Recruiting -
Cedars-Sinai Medical Center
Los Angeles, California, United States Recruiting -
Kaiser Permanente- Modesto MOB II
Modesto, California, United States Recruiting -
Kaiser Permanente-Oakland
Oakland, California, United States Recruiting -
Kaiser Permanente-Ontario
Ontario, California, United States Recruiting -
Kaiser Permanente - Panorama City
Panorama City, California, United States Recruiting -
Kaiser Permanente-Riverside
Riverside, California, United States Recruiting -
Kaiser Permanente-Roseville
Roseville, California, United States Recruiting -
Kaiser Permanente Downtown Commons
Sacramento, California, United States Recruiting -
Kaiser Permanente-South Sacramento
Sacramento, California, United States Recruiting -
Kaiser Permanente-San Diego Zion
San Diego, California, United States Recruiting -
Kaiser Permanente-San Francisco
San Francisco, California, United States Recruiting -
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States Recruiting -
Kaiser Permanente San Leandro
San Leandro, California, United States Recruiting -
Kaiser Permanente-San Marcos
San Marcos, California, United States Recruiting -
Kaiser San Rafael-Gallinas
San Rafael, California, United States Recruiting -
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States Recruiting -
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States Recruiting -
Kaiser Permanente-South San Francisco
South San Francisco, California, United States Recruiting -
Kaiser Permanente-Vallejo
Vallejo, California, United States Recruiting -
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States Recruiting -
Kaiser Permanente-Woodland Hills
Woodland Hills, California, United States Recruiting -
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States Recruiting -
Memorial Hospital North
Colorado Springs, Colorado, United States Recruiting -
Kaiser Permanente-Franklin
Denver, Colorado, United States Recruiting -
Grand Valley Oncology
Grand Junction, Colorado, United States Recruiting -
Kaiser Permanente-Rock Creek
Lafayette, Colorado, United States Recruiting -
Kaiser Permanente-Lone Tree
Lone Tree, Colorado, United States Recruiting -
Helen F Graham Cancer Center
Newark, Delaware, United States Recruiting -
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida, United States Recruiting -
Jupiter Medical Center
Jupiter, Florida, United States Recruiting -
The Watson Clinic
Lakeland, Florida, United States Recruiting -
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States Recruiting
+211 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Jayke Giese
- Email: leukemiaprotocols@alliancenctn.org
- Phone: 773-702-9171
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Venetoclax plus Zanubrutinib for CLL/SLL in frontline or previously treated patients
This phase II trial tests if venetoclax plus zanubrutinib can safely and effectively treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma, including those who are newly diagnosed and those who have had prior therapy.
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Sonrotoclax plus zanubrutinib versus venetoclax plus acalabrutinib for adults with untreated CLL
This tests whether a fixed-duration combination of sonrotoclax plus zanubrutinib works as well as or better than venetoclax plus acalabrutinib for adults with previously untreated CLL who need treatment.
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Zanubrutinib, obinutuzumab, and sonrotoclax for newly diagnosed CLL or SLL
This trial tests whether the three‑drug combination of zanubrutinib, obinutuzumab, and sonrotoclax can produce undetectable measurable residual disease (uMRD) in people with previously untreated CLL or 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.
-
Treatment of Chronic Lymphocytic Leukaemia with Pirtobrutinib after Zanubrutinib
This study is testing if the drug pirtobrutinib can help people with chronic lymphocytic leukaemia who didn’t respond to or relapsed after treatment with zanubrutinib.
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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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.