Status:
COMPLETED
Rituximab, Bortezomib,Bendamustine , Dexamethasone, Patients With Mantle Cell Lymphoma
Lead Sponsor:
French Innovative Leukemia Organisation
Collaborating Sponsors:
Janssen, LP
Mundipharma Pte Ltd.
Conditions:
Lymphoma
Eligibility:
All Genders
65-80 years
Phase:
PHASE2
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 o...
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 lympho...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00740415
Start Date
June 1 2007
End Date
August 1 2015
Last Update
March 16 2016
Active Locations (1)
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1
CHU de Grenoble - Hopital Michallon
Grenoble, France, 38043