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

NCT ID: NCT00740415

Last Updated: 2016-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2015-08-31

Brief 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.

Detailed 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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARM RiBVD

RiBVD 6 cycles every 28 days day 1 :

• Rituximab /Mabthera®, 375 mg/m2 en IV
• Bendamustine, 90 mg/m2 en IVD
• Bortezomib/Velcade®, 1,3 mg/m2 en IVD day 2 : - Bendamustine, 90 mg/m2 en IVD
• Dexamethasone, 40 mg IV day 4 : - Bortezomib/Velcade®, 1,3 mg/m2 en IVD day 8 : - Bortezomib/Velcade®, 1,3 mg/m2 en IVD day 11 : - Bortezomib/Velcade®, 1,3 mg/m2 en IVD

Group Type: EXPERIMENTAL

rituximab

Intervention Type: BIOLOGICAL

Rituximab, 375 mg/m2 Intraveinous

bortezomib

Intervention Type: DRUG

-Velcade®, 1,3 mg/m2 Intraveinous on days 1, 4, 8 and 11

dexamethasone

Intervention Type: DRUG

day - Dexamethasone, 40 mg Intraveinous

Bendamustine

Intervention Type: DRUG

-Day 1 and day 2 Bendamustine/Levact ®,, 90 mg/m2 Intraveinous

Interventions

rituximab

Rituximab, 375 mg/m2 Intraveinous

Intervention Type: BIOLOGICAL

bortezomib

-Velcade®, 1,3 mg/m2 Intraveinous on days 1, 4, 8 and 11

Intervention Type: DRUG

dexamethasone

day - Dexamethasone, 40 mg Intraveinous

Intervention Type: DRUG

Bendamustine

-Day 1 and day 2 Bendamustine/Levact ®,, 90 mg/m2 Intraveinous

Intervention Type: DRUG

Other Intervention Names

Mabthera ®,; Velcade; Levact ®

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen, LP

INDUSTRY

Sponsor Role: collaborator

Mundipharma Pte Ltd.

INDUSTRY

Sponsor Role: collaborator

French Innovative Leukemia Organisation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Remy Gressin, MD

Role: STUDY_CHAIR

CHU de Grenoble - Hopital de la Tronche

Locations

CHU de Grenoble - Hopital Michallon

Grenoble, , France

Countries

France

Related Links

http://www.filo-leucemie.org

FILO website

Other Identifiers

-MANTEAU-2010-SA

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000589544

Identifier Type: -

Identifier Source: org_study_id