Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082940
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2004-05-14
Brief Title:
Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Phase II Study of ONTAK Denileukin Diftitox DABIL-2 in Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE This phase II trial is studying how well denileukin diftitox works in treating patients with fludarabine-refractory B-cell chronic lymphocytic leukemia
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LIGAND-CCCWFU-27102 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000361734 | REGISTRY | None | None |
| CCCWFU-BG02-331 | None | None | None |