Phase II CCOP Trial of High Dose Methotrexate/ARA-C and HCVAD for Newly Diagnosed Nodular and Diffuse Mantle Cell Lymphoma and Their Blastic Variants
- Evaluate the complete response rate and duration of response in patients with newly
diagnosed diffuse or nodular mantle cell lymphoma or their blastic variant treated with
high-dose methotrexate and cytarabine and high-dose cyclophosphamide, dexamethasone,
doxorubicin, and vincristine (HCVAD).
OUTLINE: This is a multicenter study. Patients may receive either regimen A or both regimen
A and regimen B, depending upon response.
- Regimen A: Patients receive methotrexate IV over 24 hours on day 1. Cytarabine is
administered IV over 2 hours every 12 hours on days 2 and 3. Filgrastim (G-CSF) is
administered subcutaneously (SC) daily beginning on day 4 and continuing until blood
counts recover. Treatment repeats every 21 days for up to 8 courses.
- Regimen B: Patients receive cyclophosphamide IV over 3 hours every 12 hours on days
1-3. Doxorubicin is administered IV over 24 hours on days 4 and 5. Vincristine is
administered IV over 30 minutes on days 4 and 11. Dexamethasone is administered orally
or IV on days 1-4 and 11-14. G-CSF is administered SC beginning on day 6 and continuing
until blood counts recover. Treatment repeats every 21 days for up to 7 courses.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 4 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Jorge E. Romaguera, MD
M.D. Anderson Cancer Center
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|