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

Sponsor
French Innovative Leukemia Organisation
Study ID
NCT00740415
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
    Rituximab, 375 mg/m2 Intraveinous
  • bortezomib — DRUG
    -Velcade®, 1,3 mg/m2 Intraveinous on days 1, 4, 8 and 11
  • dexamethasone — DRUG
    day - Dexamethasone, 40 mg Intraveinous
  • Bendamustine — DRUG
    -Day 1 and day 2 Bendamustine/Levact ®,, 90 mg/m2 Intraveinous

Study Details

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.

Key Dates

Start date
Jun 30, 2007
Status verified
Mar 2016
Primary completion
May 31, 2011
Completion
Aug 31, 2015

Study Design

Enrollment
39 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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

Primary Outcome Measure

Overall response rate after 4 courses of therapy [ Time Frame: 4 months ]

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