Trial of Bortezomib, Cytarabine, and Dexamethasone in Mantle Cell Lymphoma
Phase 2
Completed
- Conditions
- Mantle Cell Lymphoma
- Interventions
- Registration Number
- NCT02840539
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
The purpose of this study is to determine whether bortezomib, cytarabine, and dexamethasone are effective in the treatment of relapsed or refractory mantle cell lymphoma after 1 to 3 lines of previous treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
- Pathologically confirmed mantle cell lymphoma
- Relapse or progression after 1-3 lines of previous chemotherapy with or without immunologic agents
- ECOG performance status 2 or less
- Adequate hematologic, hepatic, and renal function i. White blood cells ≥ 3,000 /ul ii. Absolute neutrophil count ≥ 1,000 /ul iii. Platelets ≥ 50,000 /ul iv. Hemoglobin ≥ 9.0 g/dL v. Total bilirubin < 2 times upper limit of normal vi. AST, ALT < 2.5 times upper limit of normal vii. Serum creatinine < 1.5 times upper limit of normal
Exclusion Criteria
- Previously treated with 4 or more lines of chemotherapy with or without immunologic agents
- Previously treated with bortezomib
- Treated with a cytarabine-containing regimen as the last line and within 6 months before registration
- Other cancer diagnosed within 5 years before registration
- Uncontrolled symptomatic CNS involvement of mantle cell lymphoma
- Uncontrolled systemic infection
- Inherited immunodeficiency disease or AIDS
- Pregnancy
- Breast-feeding
- Peripheral neuropathy of grade 3 or higher
- Other health conditions considered to be inappropriate for this trial in the primary physician's opinion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Bortezomib, Cytarabine, Dexamethasone, Pegteograstim Bortezomib, Cytarabine, Dexamethasone, Pegteograstim
- Primary Outcome Measures
Name Time Method Overall response within 28 days after the last cycle of treatment Lugano classification
- Secondary Outcome Measures
Name Time Method Complete response within 28 days after the last cycle of treatment Lugano classification
Overall survival 5 years Interval from registration to death from any cause
Progression-free survival 5 years Interval from registration to progression or death from any cause
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of