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

Lymphoma Clinical Trial

— ManteauRiBVD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740415
• Other study ID #: CDR0000589544
• Secondary ID: -MANTEAU-2010-SA
• Status: Completed
• Phase: Phase 2
• First received: August 22, 2008
• Last updated: March 15, 2016
• Start date: June 2007
• Est. completion date: August 2015

Study information

• Verified date: March 2016
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 2015
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell

Intervention

Biological:
• rituximab
Rituximab, 375 mg/m2 Intraveinous

Drug:
• bortezomib
-Velcade®, 1,3 mg/m2 Intraveinous on days 1, 4, 8 and 11
• dexamethasone
day - Dexamethasone, 40 mg Intraveinous
• Bendamustine
-Day 1 and day 2 Bendamustine/Levact ®,, 90 mg/m2 Intraveinous

Locations

Country	Name	City	State
France	CHU de Grenoble - Hopital Michallon	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
French Innovative Leukemia Organisation	Janssen, LP, Mundipharma Pte Ltd.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate after 4 courses of therapy		4 months	Yes

External Links

•   FILO website