OncoMatch/Clinical Trials/NCT05529069
Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients
Is NCT05529069 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pirtobrutinib and Venetoclax for mantle cell lymphoma.
Treatment: Pirtobrutinib · Venetoclax — To learn if the combination of pirtobrutinib (also called LOXO-305) and venetoclax can help to control mantle cell lymphoma (MCL) that is relapsed (has come back) or refractory (has not responded to therapy).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Hodgkin Lymphoma
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Biomarker criteria
Allowed: CCND1 overexpression
overexpress cyclin D1 in tissue biopsy
Allowed: CCND1 fusion
chromosome translocation t(11;14), (q13;q32)
Allowed: TP53 mutation
TP53 mutated
Allowed: TP53 deletion
del17p by FISH
Allowed: NSD2 mutation
NSD2 mutated
Allowed: NOTCH2 mutation
NOTCH2 mutated
Allowed: CDKN2A mutation
CDKN2A mutated
Allowed: MYC positive by FISH or amplification
MYC positive by FISH or MYC, Bcl2 amplification
Allowed: BCL2 amplification
Bcl2 amplification
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: BCL2 inhibitor (venetoclax)
without prior venetoclax
Lab requirements
Blood counts
platelet count ≥50,000/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); If cytopenias due to significant BM involvement, at least 30% BM involvement by MCL required
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
LVEF > 40% in the 12 months prior to enrollment; no ≥ Grade 3 NYHA heart failure; no unstable angina or acute coronary syndrome within 2 months; no MI within 3 months; no uncontrolled or symptomatic arrhythmias; QTcF ≤ 470 msec
Adequate BM function... Adequate organ function as defined by the following laboratory values... Significant cardiovascular disease defined as... Prolongation of the QT interval corrected for heart rate (QTcF) > 470 msec...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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