Phase II Study of Rituximab in Combination With Methotrexate, Doxorubicin, Cyclophosphamide, Leucovorin, Vincritine, Ifosfamide, Etoposide, Cytarabine and Mesna (R-MACLO/VAM) in Patients With Previously Untreaded Mantle Cell Lymphoma
- To evaluate progression-free survival of patients with previously untreated mantle cell
lymphoma treated with rituximab and combination chemotherapy comprising methotrexate,
doxorubicin hydrochloride, cyclophosphamide, leucovorin calcium, vincristine sulfate,
ifosfamide, etoposide, and cytarabine.
- To evaluate overall survival of patients treated with this regimen.
- To evaluate the response rate in patients treated with this regimen.
- To evaluate the toxicity of this regimen in these patients.
- Courses 1 and 3: Patients receive rituximab IV and doxorubicin hydrochloride IV on day
1; vincristine sulfate IV on days 1 and 8; cyclophosphamide IV over 30 minutes on days
1-5; methotrexate IV continuously over 24 hours on day 10; leucovorin calcium IV every
6 hours beginning beginning 36 hours after start of methotrexate infusion and
continuing until methotrexate level is below 0.05 nM; and filgrastim (G-CSF)
subcutaneously (SC) beginning on day 13 and continuing until blood counts recover.
- Courses 2 and 4: Patients receive rituximab IV on day 1; cytarabine IV over 3 hours
every 12 hours on days 1 and 2; ifosfamide IV over 1 hour and etoposide IV over 1 hour
on days 1-5; and G-CSF SC beginning on day 7 and continuing until blood counts recover.
Patients who achieve complete remission after completion of course 4 receive rituximab IV
once weekly for 4 weeks. Treatment repeats every 6 months for up to 3 years 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 yearly thereafter.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Izidore S. Lossos, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
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