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OncoMatch/Clinical Trials/NCT04840602

Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma

Is NCT04840602 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Rituximab and Ibrutinib for lymphoplasmacytic lymphoma.

Phase 2RecruitingNational Cancer Institute (NCI)NCT04840602Data as of May 2026

Treatment: Ibrutinib · Rituximab · Venetoclax · ZanubrutinibThis phase II trial studies the effects of venetoclax and rituximab in comparison to ibrutinib and rituximab or zanubrutinib in treating patients with previously untreated Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Venetoclax 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 survival. Zanubrutinib, a type of tyrosine kinase inhibitor, blocks a protein called BTK, which may help keep cancer cells from growing. Giving venetoclax and rituximab may work better in treating patients with previously untreated Waldenstrom's macroglobulinemia than ibrutinib with rituximab or zanubrutinib alone.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Performance status

ZUBROD 0–2

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy

Exception: Prior therapy with rituximab allowed if last dose ≥ 6 months prior to registration

Participants must not have had prior systemic therapy. Prior therapy with rituximab will be allowed as long as the last rituximab dose was at least 6 months prior to registration

Lab requirements

Blood counts

Platelet count ≥ 50,000 cells/mm^3; Hemoglobin ≥ 7.0 g/dL; Absolute neutrophil count (ANC) ≥ 1,000 cells/mm^3

Kidney function

Creatinine clearance (CrCl) ≥ 30 mL/min

Liver function

Total bilirubin ≤ 1.5 x IULN; AST, ALT ≤ 3 x IULN; Alkaline phosphatase ≤ 3 x IULN

Creatinine clearance (CrCl) ≥ 30 mL/min; Total bilirubin ≤ 1.5 x IULN; AST, ALT ≤ 3 x IULN; Alkaline phosphatase ≤ 3 x IULN; Platelet count ≥ 50,000 cells/mm^3; Hemoglobin ≥ 7.0 g/dL; Absolute neutrophil count (ANC) ≥ 1,000 cells/mm^3

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Banner University Medical Center - Tucson · Tucson, Arizona
  • University of Arizona Cancer Center-North Campus · Tucson, Arizona
  • UM Sylvester Comprehensive Cancer Center at Coral Gables · Coral Gables, Florida
  • UM Sylvester Comprehensive Cancer Center at Coral Springs · Coral Springs, Florida
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach · Deerfield Beach, Florida

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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