A Phase II Study of ONTAK® (Denileukin Diftitox, DABIL-2) in Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
- Determine the complete and partial response rate in patients with
fludarabine-refractory B-cell chronic lymphocytic leukemia treated with denileukin
- Determine the toxicity profile of this drug in these patients.
- Determine the response rate in patients (regardless of CD25 receptor density) treated
with this drug.
- Determine the progression-free survival and overall survival of patients treated with
OUTLINE: This is a multicenter study.
Patients receive denileukin diftitox IV over 1 hour on days 1-5. Treatment repeats every 21
days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response after 8 courses proceed to follow-up. Patients
achieving a partial response or stable disease after 8 courses may continue treatment at the
discretion of the investigator.
Patients are followed every 3 months for 1 year and then annually until relapse.
PROJECTED ACCRUAL: A total of 12-44 patients will be accrued for this study within 1 year.
Masking: Open Label, Primary Purpose: Treatment
Arthur E. Frankel, MD
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|Josephine Ford Cancer Center at Henry Ford Health System||Detroit, Michigan 48202|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Feist-Weiller Cancer Center at Louisiana State University Health Sciences||Shreveport, Louisiana 71130-3932|
|St. Joseph Hospital Regional Cancer Center - Orange||Orange, California 92868-3849|
|Gibbs Regional Cancer Center at Spartanburg Regional Medical Center||Spartanburg, South Carolina 29303|
|Cancer Care Specialists||Houma, Louisiana 70360|
|Southeastern Medical Oncology Center||Goldsboro, North Carolina 27534|
|Medical Center Vincennes||Vincennes, Indiana 47591|
|Chattanooga Oncology and Hematology Associates||Chattanooga, Tennessee 37404|
|Southwest Regional Cancer Center - Central||Austin, Texas 78705|