First-line Treatment of Mantle Cell Lymphoma of Patients Aged 65 to 80 Years. Evaluate the Efficacy, Toxicity, and Molecular Prognostic Factors of a Proteosome Inhibitor (PS341-Velcade®) in Association With Chemotherapy and Immunotherapy With Rituximab (Schema RiPAD + C)
- Evaluate the efficacy of rituximab, bortezomib, doxorubicin hydrochloride,
dexamethasone, and chlorambucil as first-line therapy in patients with stage II-IV
mantle cell lymphoma.
- Determine the complete response rate in these patients.
- Determine the efficacy, in terms of complete and overall response, by F18
- 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
- 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.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Overall response rate after 4 courses of therapy
Remy Gressin, MD
CHU de Grenoble - Hopital de la Tronche
United States: Federal Government