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OncoMatch/Clinical Trials/NCT06341556

A Multicenter, Prospective, Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma

Is NCT06341556 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Zanubrutinib for mantle cell lymphoma.

Phase 2RecruitingFudan UniversityNCT06341556Data as of Jun 2026Location: China

Treatment: ZanubrutinibThis study aims to evaluate whether maintenance therapy with Zanubrutinib monotherapy could improve the 2-year progression free survival (PFS) of patients with mantle cell lymphoma who had remission after first-line immunochemotherapy

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Zanubrutinib

Cancer type

Non-Hodgkin Lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: immunochemotherapy with CD20 monoclonal antibody — first-line

Achieved complete response (CR) or partial response (PR) through first-line sufficient treatment (including immunochemotherapy with CD20 monoclonal antibody for at least 4 cycles). Frontline induction programs include but are not limited to: R-CHOP/R-DHAP, R-CHOP, BR, etc. Previous autologous hematopoietic stem cell transplantation is allowed

Lab requirements

Blood counts

Neutrophils ≥ 1.0 × 10^9/L, PLT ≥ 50 × 10^9/L, Hb ≥ 80g/L

Kidney function

serum Cr < 1.5 x ULN, creatinine clearance rate ≥ 50 mL/min (≥ 30 mL/min if renal dysfunction caused by tumor compression)

Liver function

bilirubin ≤ 1.5 x ULN, ALT and AST < 3 x ULN, serum albumin ≥ 30 g/L

Cardiac function

Left ventricular ejection fraction (LVEF) ≥ 50% detected by echocardiography

Having sufficient organ function: a) Hematopoietic function: Neutrophils ≥ 1.0 × 10^9/L, PLT ≥ 50 × 10^9/L, Hb ≥ 80g/L; b) Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN), ALT and AST<3 x ULN, serum albumin ≥ 30 g/L; c) Renal function: serum Cr<1.5 × ULN, creatinine clearance rate ≥ 50mL/min (calculated according to the standard Cockcroft Gault formula, if renal dysfunction is caused by tumor compression, creatinine clearance rate ≥ 30mL/min); d) Left ventricular ejection fraction (LVEF) ≥ 50% detected by echocardiography; e) Coagulation function (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant therapy at the time of screening): International standardized ratio (INR) ≤ 1.5 x ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06341556 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received immunochemotherapy with CD20 monoclonal antibody.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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