Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00082940|
Recruitment Status : Completed
First Posted : May 19, 2004
Last Update Posted : January 19, 2017
RATIONALE: Biological therapies, such as denileukin diftitox, may interfere with the growth of cancer cells and slow the growth of chronic lymphocytic leukemia.
PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with fludarabine-refractory B-cell chronic lymphocytic leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: denileukin diftitox||Phase 2|
- Determine the complete and partial response rate in patients with fludarabine-refractory B-cell chronic lymphocytic leukemia treated with denileukin diftitox.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of ONTAK® (Denileukin Diftitox, DABIL-2) in Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||June 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082940
|United States, California|
|St. Joseph Hospital Regional Cancer Center - Orange|
|Orange, California, United States, 92868-3849|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611|
|United States, Indiana|
|Medical Center Vincennes|
|Vincennes, Indiana, United States, 47591|
|United States, Louisiana|
|Cancer Care Specialists|
|Houma, Louisiana, United States, 70360|
|Feist-Weiller Cancer Center at Louisiana State University Health Sciences|
|Shreveport, Louisiana, United States, 71130-3932|
|United States, Michigan|
|Josephine Ford Cancer Center at Henry Ford Health System|
|Detroit, Michigan, United States, 48202|
|United States, North Carolina|
|Southeastern Medical Oncology Center|
|Goldsboro, North Carolina, United States, 27534|
|Comprehensive Cancer Center at Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157-1082|
|United States, South Carolina|
|Gibbs Regional Cancer Center at Spartanburg Regional Medical Center|
|Spartanburg, South Carolina, United States, 29303|
|United States, Tennessee|
|Chattanooga Oncology and Hematology Associates|
|Chattanooga, Tennessee, United States, 37404|
|United States, Texas|
|Southwest Regional Cancer Center - Central|
|Austin, Texas, United States, 78705|
|Study Chair:||Arthur E. Frankel, MD||Wake Forest University Health Sciences|