OncoMatch/Clinical Trials/NCT07231952
A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)
Official title: A Phase II Study of Time-limited Combination of Pirtobrutinib, Venetoclax, and Rituximab in Treatment Naïve Patients With Waldenström's Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL) (PRoVen)
Is NCT07231952 recruiting? Yes, currently enrolling (Oct 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
Treatments studied
Immunotherapy
Targeted therapy
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 (≥ 7 g/dL if due to disease, independent of transfusions within 7 days); ANC >1000 cells/mcL (independent of growth factor support within 7 days)
Kidney function
Creatinine within normal institutional limits OR Creatinine clearance >40 mL/min
Liver function
Total bilirubin < 1.5 x ULN (up to 3x ULN if Gilbert's); AST/ALT < 3 x ULN unless due to WM, then ≤ 5 x ULN; if IgM interferes with assay, eligibility per PI discretion if other liver enzymes within protocol parameters.
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. In the event of AST or ALT unable to result due to interference of the serum IgM with the liver function tests assay, patient can still be eligible per MSK PI discretion, dependent on other liver enzymes tests being within protocol parameters.; 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana Farber Cancer Institute (Data Collection and Specimen Analysis) · Boston, Massachusetts
- 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
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.
Check if I qualifyRelated pages