The Efficacy and Safety of Bortezomib Combined With Fludarabine and Cytarabine Treatment for Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT03016988|
Recruitment Status : Not yet recruiting
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma||Drug: Bortezomib Drug: Fludarabine Drug: Cytarabine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bortezomib Combined With Fludarabine and Cytarabine for Mantle Cell Lymphoma Patients：a Single Arm, Open-labelled, Phase 2 Study|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2020|
Bortezomib,Fludarabine and Cytarabine
Bortezomib(V) 1.3mg/m2, subcutaneously,day 1,4,8,11; Fludarabine(F) 25mg/m2, intravenously day 1-3; Cytarabine(A) 500mg/m2 for 3 days(day1-3).
Bortezomib(V) 1.3mg/m2, subcutaneously,day 1,4,8,11;
Other Name: Bortezomib (PS-341)
Fludarabine(F) 25mg/m2, intravenously day 1-3;
Other Name: NSC 118218
Cytarabine(A) 500mg/m2 for 3 days(day1-3)
- Progress-free survival [ Time Frame: Follow-up to 36 months ]Interval from registration to progression or death from any cause
- Overall response rate [ Time Frame: Up to 36 months ]Lugano classification