A Single-arm, Single-center, Open-label Phase II Study of Zanubrutinib Combined With R-CHOP/R-DHAP in Newly Diagnosed Mantle CellLymphoma Patients

Inclusion Criteria

• •Histologically confirmed diagnosis of MCL according to WHO classification;
• •Previously untreated MCL.
• •Age ≥ 18 and ≤ 70 years old.
• •ECOG, 0\~2.
• •Suitable for high-dose treatment including high-dose Ara-C.
• •Stage II-IV (Ann Arbor).
• •Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI). Measurable disease was defined as at least 1 lymph node \> 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions; in case of bone marrow infiltration only, bone marrow aspiration and biopsy are mandatory for all staging evaluations.
• •The following laboratory tests during the screening period (unless related to MCL disease)
• •1\) Neutrophils ≥1×109/L within 7 days prior to study entry, and no growth factor support therapy.
• •2\) Platelets ≥75×109/L within 7 days prior to study entry without growth factor support or blood transfusion.
• •3\) Hemoglobin ≥75g/L shall not be transfused within 7 days before the test. If bone marrow is involved, neutrophils ≥0.75×109/L, platelets ≥50×109/L, hemoglobin ≥50g/L)
• •4\) Creatinine clearance ≥30ml/min
• •5\) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3× upper limit of normal (ULN).
• •International Standardized ratio (INR) ≤1.5 and activated partial prothrombin kinase time (APTT) ≤1.5×ULN. If there is a clotting factor inhibitor that causes an elevated INR or prolonged APTT, it is up to the investigator to decide whether to enroll the patient.
• •Sexually active men and women of child-bearing potential must agree to use highly effective contraceptives (eg, condoms, implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or sterilized partner) while on study; this should be maintained for 90 days after the last dose of study drug
• •Life expectancy \> 3 months.
• •Written informed consent form according to GCP and national regulations.