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 (Jun 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
Treatments studied
Immunotherapy
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.
Frequently asked questions
Is NCT07285590 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage I or II or III or IV is required.
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 qualifyRelated pages