Mantle Cell Lymphoma Clinical Trial
Official title:
Bortezomib Combined With Fludarabine and Cytarabine for Mantle Cell Lymphoma Patients：a Single Arm, Open-labelled, Phase 2 Study
Mantle cell lymphoma (MCL) is a type of non-Hodgkin's lymphoma (NHL) and shows poor survival. This study to evaluate the efficacy and safety of Bortezomib combined with Fludarabine and Cytarabine treatment in the naive and relapsed MCL who are not eligible for high dose therapy and transplantation.
The eligibility criteria were pathologically confirmed, previously untreated MCL or relapsed
MCL as defined by the World Health Organization classification; age≥18 years; Eastern
Cooperative Oncology Group (ECOG) performance status of 0-2; adequate haematologic function
(haemoglobin > 9.0 g/l, absolute neutrophil count > 1500/ml, platelets > 75,000/l), hepatic
function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine
aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal),
renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min); normal
coagulation function and electrocardiogram results. Stage was defined according to the Ann
Arbor system.
The Fujian Medical University Union Hospital approved this study before subjects were
enrolled.
Treatment dosages were as follows:
days 1,4,8,and 11 subcutaneous infusion of 1.3mg/m2 Bortezomib. Days 1-3 intravenous
infusion 25mg/m2 Fludarabine. Days 1-3 intravenous infusion of 500mg/m2 Cytarabine. The
regimen was repeated every 28 days for a maximum of six cycles.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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