Trial of Bortezomib, Cytarabine, and Dexamethasone in Mantle Cell Lymphoma

A Phase 2 Trial to Evaluate the Efficacy of Bortezomib, Cytarabine, and Dexamethasone in Patients With Relapsed or Refractory Mantle Cell Lymphoma

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.

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