OncoMatch/Clinical Trials/NCT05635162
Zanubrutinib Plus Rituximab for Patients With Indolent Mantle Cell Lymphoma
Is NCT05635162 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Zanubrutinib and Rituximab for mantle cell lymphoma.
Treatment: Zanubrutinib · Rituximab — Phase II, multicentre, randomised, open-label study to assess the benefit of early intervention with fixed duration, time-limited zanubrutinib-rituximab in indolent mantle cell lymphoma (MCL)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CCND1 overexpression
Required: CCND2 overexpression
Required: CCND3 overexpression
Required: IGH t(11;14)(q13;q32)
Disease stage
Required: Stage II, III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: any therapy for MCL
Any prior therapy for MCL, including prior radiotherapy.
Lab requirements
Blood counts
Absolute neutrophil count ≥1.0 x 10^9/L and platelets ≥75 x 10^9/L independent of growth factor support.
Kidney function
Calculated creatinine clearance ≥30 mL/min. Glomerular filtration rate (GFR) ≥30 mL/min directly measured with 24 hour urine collection, or creatinine clearance calculated according to the modified formula of Cockcroft and Gault.
Liver function
AST and/or ALT ≤3 x upper limit of normal (ULN). Total Bilirubin ≤1.5 x ULN unless due to Gilberts syndrome or of non-hepatic origin unless directly attributable to the patient's MCL.
Absolute neutrophil count ≥1.0 x 10^9/L and platelets ≥75 x 10^9/L independent of growth factor support. AST and/or ALT ≤3 x upper limit of normal (ULN). Total Bilirubin ≤1.5 x ULN unless due to Gilberts syndrome or of non-hepatic origin unless directly attributable to the patient's MCL. Calculated creatinine clearance ≥30 mL/min. Glomerular filtration rate (GFR) ≥30 mL/min directly measured with 24 hour urine collection, or creatinine clearance calculated according to the modified formula of Cockcroft and Gault.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05635162 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.
Does this trial require CCND1?
Yes, CCND1 overexpression is a required biomarker for enrollment.
Does this trial require CCND2?
Yes, CCND2 overexpression is a required biomarker for enrollment.
Does this trial require CCND3?
Yes, CCND3 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage 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