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OncoMatch/Clinical Trials/NCT07231952

A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)

Is NCT07231952 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Pirtobrutinib and Venetoclax for waldenstrom macroglobulinemia.

Phase 2RecruitingMemorial Sloan Kettering Cancer CenterNCT07231952Data as of Jun 2026

Treatment: Pirtobrutinib · Venetoclax · RituximabThe purpose of this study is to find out if the combination of pirtobrutinib, venetoclax, and rituximab is an effective treatment for participants with Waldenström's macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL)

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Rituximab

Targeted therapy

PirtobrutinibVenetoclax

Cancer type

Non-Hodgkin Lymphoma

Performance status

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

Prior therapy

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

Cannot have received: systemic therapy

Participants must not have had prior systemic therapy.

Lab requirements

Blood counts

Platelet count ≥ 50,000 cells/mm3, independent of transfusions within 7 days; Hemoglobin ≥ 8 g/dL, unless due to disease involvement in which case ≥ 7 g/dL, independent of transfusions within 7 days; Absolute neutrophil count >1000 cells/mcL, independent of growth factor support within 7 days

Kidney function

Creatinine within normal institutional limits OR Creatinine clearance >40 mL/min for patients with creatinine levels above institutional normal

Liver function

Total bilirubin < 1.5 x ULN (up to 3x ULN if Gilbert's disease); AST(SGOT)/ALT(SGPT) < 3 x ULN unless elevation is caused by liver involvement with WM in which case AST and ALT may be ≤ 5 x ULN

Cardiac function

QTcF ≤ 470 msec; LVEF > 40% in the 12 months prior to start of treatment; No ≥ Grade 3 NYHA functional classification system of heart failure; No unstable angina, acute coronary syndrome within 2 months, or myocardial infarction within 3 months prior to start of treatment; No uncontrolled or symptomatic arrhythmias

Platelet count ≥ 50,000 cells/mm3, independent of transfusions within 7 days of screening assessment; Hemoglobin ≥ 8 g/dL, unless due to disease involvement in which case ≥ 7 g/dL, independent of transfusions within 7 days of screening assessment; Absolute neutrophil count >1000 cells/mcL, independent of growth factor support within 7 days of screening assessment; Total bilirubin < 1.5 x upper normal institutional limits. In patients with Gilbert's disease total bilirubin up to 3x ULN will be allowed; AST(SGOT)/ALT(SGPT) < 3 x institutional upper limit of normal unless elevation is caused by liver involvement with WM in which case AST and ALT may be ≤ 5 x ULN; Creatinine within normal institutional limits OR Creatinine clearance >40 mL/min for patients with creatinine levels above institutional normal (by Cockcroft-Gault estimate or 12-24h creatinine clearance measurements); Adequate coagulation, defined as activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and prothrombin (PT) or (international normalized ratio (INR) not greater than 1.5 x ULN; QTcF ≤ 470 msec; LVEF > 40% in the 12 months prior to start of treatment; No ≥ Grade 3 NYHA functional classification system of heart failure; No unstable angina, acute coronary syndrome within 2 months, or myocardial infarction within 3 months prior to start of treatment; No uncontrolled or symptomatic arrhythmias

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

US trial sites

  • Beth Israel Deaconess Medical Center (Data Collection Only) · Boston, Massachusetts
  • Memorial Sloan Kettering Basking Ridge · Basking Ridge, New Jersey
  • Memoral Sloan Kettering Monmouth · Middletown, New Jersey
  • Memorial Sloan Kettering Bergen · Montvale, New Jersey
  • Memorial Sloan Kettering Suffolk - Commack · Commack, New York

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07231952 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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