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OncoMatch/Clinical Trials/NCT06561347

Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM

Is NCT06561347 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Zanubrutinib and Bendamustine for waldenstrom macroglobulinemia.

Phase 2RecruitingMassachusetts General HospitalNCT06561347Data as of May 2026

Treatment: Zanubrutinib · Bendamustine · RituximabThe purpose of this study is to determine the very good partial response (VGPR) or better rate in participants with Waldenström macroglobulinemia (WM). The names of the study drugs involved in this study are as follows: zanubrutinib, bendamustine, and rituximab.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Biomarker criteria

Allowed: MYD88 L265P mutation

MYD88 L265P mutation plus CXCR4 wild type

Allowed: CXCR4 wild-type

MYD88 L265P mutation plus CXCR4 wild type

Allowed: MYD88 L265P mutation

MYD88 L265P mutation plus CXCR4 mutation

Allowed: CXCR4 mutation

MYD88 L265P mutation plus CXCR4 mutation

Allowed: MYD88 wild-type

MYD88 wild type

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

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

Lab requirements

Blood counts

Absolute neutrophil count ≥500/mcL believed to be caused by WM bone marrow involvement; Platelets ≥30,000/mcL believed to be caused by WM bone marrow involvement; Hemoglobin ≥ 7 g/dL

Kidney function

Creatinine clearance ≥30 mL/min using the Cockcroft-Gault formula

Liver function

Total bilirubin ≤ 1.5 X institutional ULN, or ≤3 x institutional ULN with documented liver metastases and/or Gilbert's Disease; AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal, or ≤5 X institutional ULN with documented liver metastases

Participants must meet the following organ and marrow function as defined below: * Absolute neutrophil count ≥500/mcL believed to be caused by WM bone marrow involvement. Growth factors are not permitted <14 days prior to C1D1. * Platelets ≥30,000/mcL believed to be caused by WM bone marrow involvement. Platelet transfusions are not permitted <14 days prior to C1D1. * Hemoglobin ≥ 7 g/dL. RBC transfusions are not permitted <14 days prior to C1D1. * Total bilirubin ≤ 1.5 X institutional ULN, or ≤3 x institutional ULN with documented liver metastases and/or Gilbert's Disease * AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal, or ≤5 X institutional ULN with documented liver metastases * Creatinine clearance ≥30 mL/min using the Cockcroft-Gault formula

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

US trial sites

  • Colorado Blood Cancer Institute (CBCI) · Denver, Colorado
  • Massachusetts General Hospital · Boston, Massachusetts
  • Beth Israel Deaconess Medical Center · Boston, Massachusetts
  • Dana Farber Cancer Institute · Boston, Massachusetts
  • University of Texas Southwestern Medical Center · Dallas, Texas

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