Phase II Study of Irinotecan for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
- Determine the objective response rate and toxicity of irinotecan when administered to
patients with recurrent or refractory non-Hodgkin's lymphoma.
OUTLINE: Patients are stratified by disease category (aggressive vs indolent vs mantle cell
lymphoma). Patients with aggressive and indolent lymphoma are further stratified as to being
refractory (no complete response (CR) or partial response (PR) to initial therapy) vs
recurrent (CR or PR to initial therapy); i.e, the following subcategories are used:
- Stratum I:Refractory aggressive non-Hodgkin's lymphoma (NHL)
- Stratum II:Recurrent aggressive NHL
- Stratum III: Refractory indolent NHL
- Stratum IV: Recurrent indolent NHL
- Stratum V: Mantle cell NHL All patients receive irinotecan intravenously every 21 days.
Patients achieving CR or PR receive 6 courses. Patients may receive bone marrow
transplantation after at least 2 courses.
Patients are followed every 3 months for survival.
PROJECTED ACCRUAL: This study will accrue 18 patients per stratum; if at least three
patients respond, an additional 25 patients will be accrued for a total of 43 evaluable
patients per stratum. The total number accrued will be 90-215 over a period of approximately
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Andre Goy, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|