OncoMatch/Clinical Trials/NCT07285590
Clinical Trial to Evaluate the Efficacy and Safety of Pirtobrutinib With Rituximab in Patients With Mantle Cell Lymphoma
Is NCT07285590 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pirtobrutinib and rituximab for mantle cell lymphoma (mcl).
Treatment: Pirtobrutinib and rituximab — This is a multicenter, international, open-label, single-arm phase II clinical trial designed to evaluate the activity and safety of a combination therapy with pirtobrutinib and rituximab (P-R) in treatment-naïve adult patients diagnosed with indolent clinical forms of Mantle Cell Lymphoma (MCL). The study applies a Simon's two-stage design, with an interim analysis after the first 16 patients to determine continuation based on complete remission rate (CRR) after 6 cycles.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Disease stage
Required: Stage I, II, III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: any therapy for MCL
Exception: diagnostic splenectomy allowed
Naïve patients for MCL management (no prior therapies, excluding diagnostic splenectomy)
Cannot have received: experimental drug unrelated to MCL
Not included in other clinical trial or treated with an experimental drug unrelated to MCL within the past 2 years
Lab requirements
Blood counts
Neutrophil count ≥ 1×10^9/L, Haemoglobin level ≥ 100 g/L, platelet count ≥100×10^9/L; Adequate coagulation: aPTT/PTT and PT/INR not greater than 1.5 x ULN
Kidney function
Calculated creatinine clearance ≥ 30 ml/min according to Cockcroft/Gault Formula; creatinine level > 2 mg/dl [excluded]
Liver function
Transaminases (AST and ALT) ≤ 3 x ULN; Total bilirubin ≤1.5 x ULN unless bilirubin rise is due to Gilbert's disease
Cardiac function
LVEF > 40% in the 12 months prior to inclusion; QTcF ≤ 470 msec
Neutrophil count ≥ 1×10^9/L, Haemoglobin level ≥ 100 g/L and platelet count ≥100×10^9/L; Transaminases (AST and ALT) ≤ 3 x ULN; Total bilirubin ≤1.5 x ULN unless bilirubin rise is due to Gilbert's disease; Calculated creatinine clearance ≥ 30 ml/min according to Cockcroft/Gault Formula; 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. Organ dysfunction related to MCL including creatinine level > 2 mg/dl or altered liver biochemistry (> 3x ULN) [excluded]. Prolongation of the QT interval corrected for heart rate (QTcF) > 470 msec. LVEF ≤ 40% in the 12 months prior to inclusion [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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