Phase II Study of Intensified CVP, Rituximab, and High Dose Cyclophosphamide for Adult Burkitt or Burkitt-Like Lymphoma
- Determine the overall response rate, 1-year event-free survival, and overall survival
of adult patients with newly diagnosed Burkitt or atypical Burkitt lymphoma or leukemia
treated with dose-intensified induction therapy comprising cyclophosphamide,
vincristine, prednisone, and rituximab followed by consolidation therapy comprising
rituximab and high-dose cyclophosphamide.
- Determine the grade 3 or higher non-hematologic toxic effects and overall tolerability
of this regimen in these patients.
- Determine the 3-year event-free survival and overall survival of patients treated with
- Determine the general patterns of CNS and systemic relapse in patients treated with
OUTLINE: This is a multicenter study.
- Dose-intensified CVP induction therapy: Patients receive cyclophosphamide IV and
vincristine IV on day 1. Patients also receive oral prednisone on days 1-5 and
rituximab IV on days 1 and 8, and high-dose methotrexate IV with leucovorin calcium IV
rescue on day 8. Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily
beginning on day 3 and continuing until blood counts recover. Treatment repeats
approximately every 14 days for 2 courses.
- CNS therapy: Patients receive cytarabine intrathecally (IT) with or without
hydrocortisone IT on days 1, 4, and 11 of each induction therapy course. Patients with
evidence of CNS involvement by lymphoma continue to receive cytarabine IT twice weekly
during any induction therapy treatment delay. Patients who demonstrate CSF clearance
receive cytarabine IT once weekly for 4 doses and then once every other week for 4
doses during consolidation therapy. Patients with disease progression during induction
therapy or persistent CNS involvement by lymphoma are removed from the study. All other
patients proceed to consolidation therapy.
- Consolidation therapy: Patients receive rituximab IV on day -4 and high-dose
cyclophosphamide IV on days -3, -2, -1, and 0. Patients receive G-CSF SC once daily
beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once
on day 6. Patients then receive rituximab IV once weekly for 4 weeks in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.
Masking: Open Label, Primary Purpose: Treatment
Overall response rate
Yvette L. Kasamon, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
|Drexel University College of Medicine - Center City Hahnemann Campus||Philadelphia, Pennsylvania 19102|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|