OncoMatch/Clinical Trials/NCT06839053
Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma
Is NCT06839053 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Rituximab and Sonrotoclax for chronic lymphocytic leukemia.
Treatment: Rituximab · Sonrotoclax · Zanubrutinib — This phase II trial studies the side effects of an escalated ramp-up of sonrotoclax following initial debulking with zanubrutinib or rituximab in treating patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL) that is newly diagnosed, has come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Rituximab is a monoclonal antibody that binds to a protein called CD20, which is found on B-cells, and may kill tumor cells. Zanubrutinib may stop the growth of tumor cells by blocking a protein called Bruton's tyrosine kinase (BTK), which is needed for tumor cell growth. Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (BCL-2). This protein helps certain types of blood tumor cells to survive and grow. When sonrotoclax blocks Bcl-2 it slows down or stops the growth of tumor cells and helps them die. Giving an increased dose of sonrotoclax over a shorter period of time in combination with zanubrutinib or rituximab may be safe and tolerable in treating patients with newly diagnosed, relapsed or refractory CLL, SLL, and MCL.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — CLL/SLL (R/R cohort)
For the R/R cohort, disease that relapsed after, or was refractory to, at least 1 prior therapy
Must have received: systemic therapy — MCL (R/R cohort)
R/R MCL is defined as a disease that relapsed after, or was refractory to, at least 1 prior systemic therapy
Cannot have received: Bcl-2 inhibitor
Exposure to a Bcl-2 inhibitor within the last 12 months or a history of disease progression while taking a Bcl-2 inhibitor
Cannot have received: allogeneic stem cell transplant
Exception: active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for the treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent
Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for the treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent
Lab requirements
Blood counts
ANC >= 1.0 x 10^9/L (>= 0.75 x 10^9/L if bone marrow involvement); platelets > 75,000 x 10^9/L (> 50,000 x 10^9/L if bone marrow involvement); hemoglobin > 75 g/L
Kidney function
Creatinine clearance or GFR >= 50 mL/min (Cockcroft-Gault, CKD-EPI, or 24-hour urine collection)
Liver function
AST/ALT <= 2 x ULN; total bilirubin <= 1.5 x ULN (unless documented Gilbert's syndrome; direct bilirubin <= 1.0 x ULN if Gilbert's syndrome); serum amylase <= 1.5 x ULN; serum lipase <= 1.5 x ULN
ANC >= 1.0 x 10^9/L; platelets > 75,000 x 10^9/L; hemoglobin > 75 g/L; creatinine clearance or GFR >= 50 mL/min; AST/ALT <= 2 x ULN; total bilirubin <= 1.5 x ULN (unless documented Gilbert's syndrome; direct bilirubin <= 1.0 x ULN if Gilbert's syndrome); serum amylase <= 1.5 x ULN; serum lipase <= 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06839053 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior Bcl-2 inhibitor, allogeneic stem cell transplant disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify