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 (May 2026). This Phase 2 trial studies multiple treatments including Pirtobrutinib and Venetoclax for waldenstrom macroglobulinemia.
Treatment: Pirtobrutinib · Venetoclax · Rituximab — The 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
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 →
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