OncoMatch/Clinical Trials/NCT06263491
Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients
Is NCT06263491 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Rituximab and Pirtobrutinib for mantle cell lymphoma.
Treatment: Rituximab · Pirtobrutinib — To learn if the chemotherapy-free combination of pirtobrutinib (also called LOXO-305) and rituximab can help provide long term remission in low and intermediate risk MCL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD20 positivity
CD20 positivity is needed
Excluded: TP53 mutation
TP53 mutated or del17p by FISH
Excluded: TP53 deletion (del17p)
TP53 mutated or del17p by FISH
Excluded: MYC rearrangement
Presence of MYC rearrangement positive by FISH
Excluded: BCL2 amplification
Bcl2 amplification
Allowed: CCND1 negative
Cyclin D1 negative MCL are allowed after confirming the diagnosis of MCL from hem-path at MDACC
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
platelet count ≥75,000/mm3; ANC ≥ 1000/mm3 unless cytopenia is clearly due to marrow involvement from MCL; total hemoglobin ≥ 8 g/dL (without transfusion support within 2 weeks of screening); cytopenias due to significant BM involvement (≥30% BM involvement by MCL) may be allowed after discussion with PI/Co-PI
Kidney function
Creatinine clearance ≥30 mL/min (by Cockcroft-Gault method)
Liver function
Total bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN with documented liver involvement and/or Gilbert's Disease or controlled immune hemolysis or considered an effect of regular blood transfusions. ALT and AST <3 x ULN, or < 5 x ULN if hepatic metastases are present.
Cardiac function
Ejection fraction ≥50% and cardiology evaluation may be needed. Prothrombin time (or INR) and partial thromboplastin time not to exceed 1.2 times the institutional upper limit of normal range (participants with an elevated prothrombin time and known lupus anticoagulant may be eligible after consulting the study PI).
Adequate BM function independent of growth factor or PRBC or platelet transfusion support... Adequate organ function as defined by the following laboratory values: Creatinine clearance. ≥30 mL/min... Total bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN with documented liver involvement and/or Gilbert's Disease or controlled immune hemolysis or considered an effect of regular blood transfusions. ALT and AST <3 x ULN, or < 5 x ULN if hepatic metastases are present. Prothrombin time (or international normalized ratio) and partial thromboplastin time not to exceed 1.2 times the institutional upper limit of normal range...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
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