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OncoMatch/Clinical Trials/NCT05635162

Zanubrutinib Plus Rituximab for Patients With Indolent Mantle Cell Lymphoma

Is NCT05635162 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Zanubrutinib and Rituximab for mantle cell lymphoma.

Phase 2RecruitingUniversity College, LondonNCT05635162Data as of May 2026

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)

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Extracted eligibility criteria

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

No prior treatment (treatment-naive required)
Max 0 prior lines

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.

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