OncoMatch/Clinical Trials/NCT05734495
Pirtobrutinib and Venetoclax in Waldenström Macroglobulinemia
Is NCT05734495 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pirtobrutinib and Venetoclax for waldenstrom macroglobulinemia.
Treatment: Pirtobrutinib · Venetoclax — This study is being done to examine the safety and effectiveness of pirtobrutinib combined with venetoclax as a possible treatment for participants with Waldenström Macroglobulinemia (WM). The names of the study drugs involved in this study are: * Pirtobrutinib (a Noncovalent Bruton Tyrosine Kinase (BTK) inhibitor) * Venetoclax (a BCL2 inhibitor)
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: MYD88 wild-type
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: non-covalent btk inhibitor
Lab requirements
Blood counts
Absolute neutrophil count ≥750/uL (may enroll below if bone marrow involvement); Platelets ≥50,000/uL not requiring transfusion support (may enroll below if bone marrow involvement); Hemoglobin ≥ 8 g/dL not requiring transfusion support or growth factors (may enroll below if bone marrow involvement or hemolysis)
Kidney function
Creatinine clearance ≥ 30 ml/min using Cockcroft/Gault formula
Liver function
Total bilirubin ≤ 1.5 X ULN, or ≤3 x ULN with documented liver involvement, hemolysis, or Gilbert's Disease; AST(SGOT)/ALT(SGPT) ≤3 × institutional upper limit of normal, or ≤5 X ULN with documented liver involvement
Cardiac function
QTcF > 470 msec on at least 2/3 consecutive ECGs, and mean QTcF > 470 msec on all 3 ECGs, during Screening (exclusion); Significant cardiovascular disease defined as: unstable angina, history of myocardial infarction within 6 months, LVEF ≤ 45% in prior 12 months, NYHA Class 3 or 4, uncontrolled or symptomatic arrhythmias
Participants must have normal organ and marrow function as defined below: Absolute neutrophil count ≥750/uL... Platelets ≥50,000/uL... Hemoglobin ≥ 8 g/dL... Total bilirubin ≤ 1.5 X ULN... AST(SGOT)/ALT(SGPT) ≤3 × institutional upper limit of normal... Creatinine clearance ≥ 30 ml/min... Prolongation of the QT interval corrected for heart rate (QTcF) > 470 msec... Significant cardiovascular disease defined as: Unstable angina, history of myocardial infarction within 6 months, LVEF ≤ 45% in prior 12 months, NYHA Class 3 or 4, uncontrolled or symptomatic arrhythmias
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Beth Israel Deaconness Medical · Boston, Massachusetts
- Dana Farber Cancer Institute · Boston, Massachusetts
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