Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138164
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2005-08-29
Brief Title:
Denileukin Diftitox in Treating Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Multicenter Study of Ontak Denileukin Diftitox in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2008-11
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 be able to carry cancer-killing substances directly to non-Hodgkins lymphoma cells
PURPOSE This phase II trial is studying how well denileukin diftitox works in treating patients with relapsed or refractory B-cell non-Hodgkins lymphoma
PURPOSE This phase II trial is studying how well denileukin diftitox works in treating patients with relapsed or refractory B-cell non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of denileukin diftitox in terms of objective response and time to progression in patients with relapsed or refractory B-cell non-Hodgkins lymphoma
Secondary
Determine the safety of this drug in these patients
Determine the 1-year overall survival of patients treated with this drug
OUTLINE This is an open-label multicenter study
Patients receive denileukin diftitox IV over 20-80 minutes on days 1-3 8 15 22 29 36 43 50 57 64 71 78 85 92 and 99 weeks 1-16 in the absence of disease progression or unacceptable toxicity Patients achieving a partial response at week 16 may continue treatment once monthly for up to 8 additional doses or until a complete response CR is achieved Patients achieving a CR at any time receive 2 additional monthly doses of denileukin diftitox beyond CR
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 25-50 patients will be accrued for this study within 1 year
Primary
Determine the efficacy of denileukin diftitox in terms of objective response and time to progression in patients with relapsed or refractory B-cell non-Hodgkins lymphoma
Secondary
Determine the safety of this drug in these patients
Determine the 1-year overall survival of patients treated with this drug
OUTLINE This is an open-label multicenter study
Patients receive denileukin diftitox IV over 20-80 minutes on days 1-3 8 15 22 29 36 43 50 57 64 71 78 85 92 and 99 weeks 1-16 in the absence of disease progression or unacceptable toxicity Patients achieving a partial response at week 16 may continue treatment once monthly for up to 8 additional doses or until a complete response CR is achieved Patients achieving a CR at any time receive 2 additional monthly doses of denileukin diftitox beyond CR
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 25-50 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 |
|---|---|---|---|
| CDR0000439451 | REGISTRY | PDQ Physician Data Query | None |
| UCLA-0412087-01 | None | None | None |