Clinical trial NCT00740415: Rituximab, Bortezomib,Bendamustine , Dexamethasone, Patients With Mantle Cell Lymphoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
Collaborators: name: Janssen, LP
name: Mundipharma Pte Ltd.
First posted: 2008-08-25
Enrollment: 39
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Overall response rate after 4 courses of therapy
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble - Hopital Michallon
Study officials:
affiliation: CHU de Grenoble - Hopital de la Tronche
name: Remy Gressin, MD
role: STUDY_CHAIR
References: