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

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Consortium for Improving Survival of Lymphoma
• Treatments: BB 1101; Bortezomib; Cytarabine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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