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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 (May 2026). This Phase 2 trial studies multiple treatments including Rituximab and Sonrotoclax for chronic lymphocytic leukemia.

Phase 2RecruitingFred Hutchinson Cancer CenterNCT06839053Data as of May 2026

Treatment: Rituximab · Sonrotoclax · ZanubrutinibThis 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.

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Extracted eligibility criteria

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 — relapsed/refractory CLL/SLL or MCL

disease that relapsed after, or was refractory to, at least 1 prior therapy

Cannot have received: BCL2 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: autologous stem cell transplant

Exception: unless >= 3 months after transplant

Prior autologous stem cell transplant unless >= 3 months after transplant

Cannot have received: CAR-T cell therapy

Exception: unless >= 3 months after cell infusion

prior chimeric antigen receptor T-cell (CAR-T) therapy unless >= 3 months after cell infusion

Cannot have received: allogeneic stem cell transplant

Exception: 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

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

Cannot have received: biologic and/or immunologic-based therapy (rituximab)

Any biologic and/or immunologic-based therapy(ies) including experimental therapy(ies) for leukemia, lymphoma, or myeloma (including, but not limited to, monoclonal antibody therapy, e.g., rituximab, and/or cancer vaccine therapy) <= 28 days before the first dose

Cannot have received: systemic chemotherapy

Systemic chemotherapy or radiation therapy <= 14 days before the first dose

Cannot have received: radiation therapy

Systemic chemotherapy or radiation therapy <= 14 days before the first dose

Cannot have received: corticosteroid

Corticosteroid given with antineoplastic intent <= 7 days before the first dose

Cannot have received: Bruton's tyrosine kinase inhibitor

Bruton's tyrosine kinase inhibitor (BTKi) or other small molecule inhibitor is given with antineoplastic intent <= 3 days (or 5 half-lives; whichever is shorter) before the first dose

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/SGOT <= 2 x ULN; ALT/SGPT <= 2 x ULN; total bilirubin <= 1.5 x ULN (unless documented Gilbert's syndrome, then direct bilirubin <= 1.0 x ULN); serum amylase <= 1.5 x ULN; serum lipase <= 1.5 x ULN

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; Creatinine clearance or GFR >= 50 mL/min; AST/SGOT <= 2 x ULN; ALT/SGPT <= 2 x ULN; total bilirubin <= 1.5 x ULN (unless documented Gilbert's syndrome, then direct bilirubin <= 1.0 x ULN); 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 →

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