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
- Determine the progression-free survival of patients with previously untreated mantle
cell lymphoma treated with rituximab and combination chemotherapy comprising
vincristine, doxorubicin hydrochloride, cyclophosphamide, methotrexate, ifosfamide,
cytarabine, and etoposide followed by thalidomide.
- 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: Patients receive rituximab IV and doxorubicin hydrochloride IV over 3-5 minutes on
day 1, vincristine IV on days 1 and 8, cyclophosphamide IV over 30 minutes on days 1-5,
methotrexate IV over 24 hours on day 10, and leucovorin calcium IV every 6 hours beginning
on day 11 and continuing until the level of methotrexate in the blood is within a safe
range. Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day
13 and continuing until blood counts recover. When absolute neutrophil count (ANC) reaches
1,500/mm^3, patients receive rituximab IV on day 1 (i.e., the day ANC reaches 1,500/mm^3),
ifosfamide IV over 1 hour on days 1-5, cytarabine IV over 3 hours every 12 hours on days 1
and 2, and etoposide IV over 1 hour on days 1-5. Patients also receive G-CSF SC once daily
beginning on day 7 and continuing until blood counts recover. Approximately 2-3 weeks later,
patients receive another course of therapy as above.
Patients in complete remission after 2 courses of rituximab and combination chemotherapy
receive oral thalidomide daily. Treatment with thalidomide continues for 1 year in the
absence of disease progression or unacceptable toxicity.
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.
PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival at 6, 12, 18, and 24 months
6, 12, 18, and 24 months
Izidore S. Lossos, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
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