A Phase II Study of ONTAK® (Denileukin Diftitox, DABIL-2) in Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
OBJECTIVES:
Primary
- Determine the complete and partial response rate in patients with
fludarabine-refractory B-cell chronic lymphocytic leukemia treated with denileukin
diftitox.
Secondary
- 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
this drug.
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Arthur E. Frankel, MD
Study Chair
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
CCCWFU-27102
NCT00082940
August 2002
June 2005
Name | Location |
---|---|
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 |