Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026429
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2001-11-09
Brief Title:
Denileukin Diftitox in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
Pharmatech Oncology
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicenter Phase II Evaluation Of ONTAK DENILEUKINDIFTITOX In Patients With Low Or Intermediate Grade-B-Cell Non-Hodgkins Lymphoma Who Have Been Treated Previously With A Monoclonal Antibody Or Who Are Not Candidates For Monoclonal Antibody Therapy
Status:
UNKNOWN
Status Verified Date:
2002-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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 deliver cancer-killing substances directly to non-Hodgkins lymphoma cells
PURPOSE Phase II trial to study the effectiveness of denileukin diftitox in treating patients who have non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of denileukin diftitox in treating patients who have non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the efficacy of denileukin diftitox in patients with stages I-IV low- or intermediate-grade B-cell non-Hodgkins lymphoma II Determine the safety of this drug in these patients
OUTLINE This is a multicenter study Patients receive denileukin diftitox IV over 30-60 minutes on days 1-5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients may receive up to 2 additional courses after achieving complete response Patients are followed every 3 months until they have progressed or for 2 years from date of termination
PROJECTED ACCRUAL A total of 58 patients 29 with low-grade non-Hodgkins lymphoma NHL and 29 with intermediate-grade NHL will be accrued for this study within 12 months The study may be stopped after accrual of 20 patients 10 with low-grade NHL and 10 with intermediate-grade NHL if observed response rate is less than 1 in 10 for each stratum
OUTLINE This is a multicenter study Patients receive denileukin diftitox IV over 30-60 minutes on days 1-5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients may receive up to 2 additional courses after achieving complete response Patients are followed every 3 months until they have progressed or for 2 years from date of termination
PROJECTED ACCRUAL A total of 58 patients 29 with low-grade non-Hodgkins lymphoma NHL and 29 with intermediate-grade NHL will be accrued for this study within 12 months The study may be stopped after accrual of 20 patients 10 with low-grade NHL and 10 with intermediate-grade NHL if observed response rate is less than 1 in 10 for each stratum
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PHARMATECH-20002024 | None | None | None |
| PHARMATECH-LP-ONT-BL | None | None | None |
| LIGAND-PHARMATECH-LP-ONT-BL | None | None | None |