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 (Jun 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
Treatments studied
Targeted therapy
Cancer type
Non-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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05529069 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior BCL2 inhibitor disqualifies patients from enrollment.
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 qualify