Lymphoma
Conditions
Keywords
contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma
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.
Interventions
BIOLOGICALrituximab
Rituximab, 375 mg/m2 Intraveinous
DRUGbortezomib
-Velcade®, 1,3 mg/m2 Intraveinous on days 1, 4, 8 and 11
DRUGdexamethasone
day - Dexamethasone, 40 mg Intraveinous
DRUGBendamustine
-Day 1 and day 2 Bendamustine/Levact ®,, 90 mg/m2 Intraveinous
Sponsors
Janssen, LP
Mundipharma Pte Ltd.
French Innovative Leukemia Organisation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate after 4 courses of therapy | 4 months |
Countries
France
Outcome results
None listed