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
OBJECTIVES:
Primary
- 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.
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: 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.
Interventional
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
No
Izidore S. Lossos, MD
Study Chair
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
EPROST-20030165
NCT00450801
April 2004
April 2014
Name | Location |
---|---|
University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |