Rituximab, Bortezomib,Bendamustine , Dexamethasone, Patients With Mantle Cell Lymphoma

OBJECTIVES:

Primary

• Evaluate the efficacy of rituximab, bortezomib, doxorubicin hydrochloride, dexamethasone, and chlorambucil as first-line therapy in patients with stage II-IV mantle cell lymphoma.

Secondary

• Determine the complete response rate in these patients.
• Determine the efficacy, in terms of complete and overall response, by F18 fludeoxyglucose scan.
• Determine overall, disease-free, and event-free survival of these patients.
• Assess tolerability of this regimen in these patients.
• Evaluate the impact of factors, described in previous protocols, on response to therapy and survival.
• Assess the impact of residual disease in cerebrospinal fluid on survival.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV on day 1 (days 1 and 8 of the first course only); bortezomib IV on days 1, 4, 8, and 11; doxorubicin hydrochloride IV continuously over 24 hours on days 1-4; dexamethasone IV on days 1-4; and oral chlorambucil on days 20-29. Treatment repeats every 5 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients who achieve at least 50% response receive 2 additional courses of therapy.

DISEASE CHARACTERISTICS:

• Diagnosis of mantle cell lymphoma

• Stage II-IV disease
• No neuromeningeal disease

PATIENT CHARACTERISTICS:

• WHO performance status 0-2
• No prior cancer except for carcinoma in situ of the cervix or basal cell skin cancer
• LVEF > 50%
• HIV-negative
• Hepatitis B- and C-negative
• No hepatocellular, renal, or bone marrow insufficiency unrelated to lymphoma

PRIOR CONCURRENT THERAPY:

• Not specified