Rituximab, Bortezomib,Bendamustine , Dexamethasone, Patients With Mantle Cell Lymphoma (ManteauRiBVD)
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin, dexamethasone, and chlorambucil, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy together with rituximab and bortezomib may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with bortezomib, doxorubicin, dexamethasone, and chlorambucil works as first-line therapy in treating older patients with stage II, stage III, or stage IV mantle cell lymphoma.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||First-line Treatment of Mantle Cell Lymphoma of Old Patients . Evaluate the Efficacy, Toxicity, and Molecular Prognostic Factors of Velcade®) in Association With Chemotherapy and Immunotherapy With Rituximab|
- Overall response rate after 4 courses of therapy [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2007|
|Study Completion Date:||August 2015|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: ARM RiBVD
RiBVD 6 cycles every 28 days day 1 :
Rituximab, 375 mg/m2 Intraveinous
Other Name: Mabthera ®,Drug: bortezomib
-Velcade®, 1,3 mg/m2 Intraveinous on days 1, 4, 8 and 11
Other Name: VelcadeDrug: dexamethasone
day - Dexamethasone, 40 mg IntraveinousDrug: Bendamustine
-Day 1 and day 2 Bendamustine/Levact ®,, 90 mg/m2 Intraveinous
Other Name: Levact ®
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740415
|CHU de Grenoble - Hopital Michallon|
|Grenoble, France, 38043|
|Study Chair:||Remy Gressin, MD||CHU de Grenoble - Hopital de la Tronche|