Trial of Bortezomib, Cytarabine, and Dexamethasone in Mantle Cell Lymphoma (BATMAN)

Seoul National University

Status and phase

Completed

Phase 2

Conditions

Mantle Cell Lymphoma

Treatments

Drug: Bortezomib, Cytarabine, Dexamethasone, Pegteograstim

Study type

Interventional

Funder types

Other

Identifiers

NCT02840539

SNUH-1602-153-747

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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