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 (May 2026). This Phase 2 trial studies Zanubrutinib for mantle cell lymphoma.
Treatment: Zanubrutinib — This 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
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.
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