Rituximab and Combination Chemotherapy Followed By Thalidomide in Treating Patients With Previously Untreated Mantle Cell Lymphoma
This trial is active, not recruiting.
|Treatments||rituximab, cyclophosphamide, cytarabine, doxorubicin, etoposide, ifosfamide, leucovorin, methotrexate, thalidomide, vincristine, mesna, filgrastim (g-csf), granisetron, decadron|
|Sponsor||University of Miami|
|Start date||April 2004|
|End date||April 2015|
|Trial size||22 participants|
|Trial identifier||NCT00450801, 20030165, SCCC-2003027, WIRB-20051242|
RATIONALE: To evaluate the efficacy of a new high intensity chemotherapy regimen with thalidomide maintenance in patients with newly diagnosed mantle cell lymphoma
PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy followed by thalidomide works in treating patients with previously untreated mantle cell lymphoma.
|Intervention model||single group assignment|
Progression-free survival at 6, 12, 18, and 24 months
time frame: 6, 12, 18, and 24 months
Male or female participants from 18 years up to 64 years old.
Inclusion Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed mantle cell lymphoma - All stages allowed - Previously untreated disease - Measurable or evaluable disease - No CNS involvement PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Life expectancy > 6 months - Bilirubin < 3 mg/dL - SGOT and/or SGPT < 2.5 times upper limit of normal (unless due to lymphomatous involvement) - Creatinine < 1.5 mg/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective double-method contraception during and for ≥ 4 weeks after completion of study treatment (if receiving thalidomide) - No other concurrent active malignancies, except for in situ carcinoma of the cervix or basal cell carcinoma of the skin Exclusion Criteria: Grade 3-4 cardiac failure - LVEF that is less than ≥ 50% - psychological, familial, sociological, or geographical conditions that would preclude study compliance - known history of HIV or AIDS - hepatitis or hepatitis B virus infection PRIOR CONCURRENT THERAPY: - Any prior chemotherapy, immunotherapy, or radiotherapy for this lymphoma
|Official title||Phase II Study of Rituximab in Combination With Methotrexate, Doxorubicin, Cyclophosphamide, Leucovorin, Vincristine, Ifosfamide, Etoposide, Cytarabine and Mesna (Maclo/Ivam) in Patients With Previously Untreated Mantle Cell Lymphoma|
|Description||OBJECTIVES: Primary - Determine the progression-free survival of patients with previously untreated mantle cell lymphoma treated rituximab in combination with methotrexate, doxorubicin, cyclophosphamide, leucovorin, vincristine, ifosfamide, etoposide, cytarabine and mesna (MACLO/IVAM) followed by thalidomide. Secondary - Determine the overall survival of patients treated with this regimen. - Determine the response rate in patients treated with this regimen. - Determine the toxicity of this regimen in these patients. OUTLINE: During cycle 1, patients will receive rituximab IV, granisetron IV, decadron IV, doxorubicin IV bolus, vincristine IVP on day 1; cyclophosphamide IV on day 1-5; vincristine IVP on day 8; methotrexate IV, methotrexate by continuous infusion, then leucovorin IV until methotrexate level is below 0.01 nM on day 10. Patients will receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 13 and continuing until blood counts recover. When absolute neutrophil count (ANC) reaches1,500/mm^3, patients will start cycle 2. Patients will receive rituximab IV on day 1; cytarabine IV on day 1 and 2; ifosfamide IV, mesna IV, etoposide IV on day 1-5; and G-CSF SC daily beginning on day 7 and continuing until ANC is greater than 1,000 cells/mm^3. Approximately 2-3 weeks later, patients receive another course of therapy as above.After cycle 4, patients in complete remission will take oral thalidomide until progression of disease. After completion of study treatment, patients are followed monthly for 3 months, every 3 months for 2 years, every 6 months for 3-5 years, and then annually thereafter or at study termination. PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study.|
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