Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003966
Status:
COMPLETED
Last Update Posted:
2017-01-20
First Post:
1999-11-01
Brief Title:
Defibrotide in Treating Patients With Liver Damage Following Peripheral Stem Cell Transplantation
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Defibrotide for Hematopoietic Stem Cell Transplant Patients With Severe Hepatic Venocclusive Disease A Phase III Study to Determine the Minimal Effective Dose
Status:
COMPLETED
Status Verified Date:
2017-01
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 Giving defibrotide may be an effective treatment for liver damage that may result following peripheral stem cell transplantation
PURPOSE This randomized phase II trial is studying defibrotide to see how well it works in treating patients with severe liver disease after undergoing peripheral stem cell transplantation
PURPOSE This randomized phase II trial is studying defibrotide to see how well it works in treating patients with severe liver disease after undergoing peripheral stem cell transplantation
Detailed Description:
OBJECTIVES
Determine complete response rate in post-hematopoietic stem cell transplant patients with severe veno-occlusive disease of the liver treated with defibrotide
Determine the minimal effective dose of this drug in these patients
Assess toxicity and adverse side effects of this drug in these patients
OUTLINE This is a randomized multicenter study All patients initially receive the same dose of defibrotide IV over 2 hours every 6 hours on day 1 On day 2 patients are randomized to 1 of 2 doses of defibrotide
Arm I On days 2-14 patients receive a lower dose of defibrotide IV over 2 hours every 6 hours
Arm II On days 2-14 patients receive a higher dose of defibrotide IV over 2 hours every 6 hours
In both arms courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 140 patients 70 per treatment arm will be accrued for this study
Determine complete response rate in post-hematopoietic stem cell transplant patients with severe veno-occlusive disease of the liver treated with defibrotide
Determine the minimal effective dose of this drug in these patients
Assess toxicity and adverse side effects of this drug in these patients
OUTLINE This is a randomized multicenter study All patients initially receive the same dose of defibrotide IV over 2 hours every 6 hours on day 1 On day 2 patients are randomized to 1 of 2 doses of defibrotide
Arm I On days 2-14 patients receive a lower dose of defibrotide IV over 2 hours every 6 hours
Arm II On days 2-14 patients receive a higher dose of defibrotide IV over 2 hours every 6 hours
In both arms courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 140 patients 70 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| JHMI-00-06-02-02 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA015704 |
| P30CA015704 | NIH | None | None |
| DFCI-1999-P-01007614 | None | None | None |
| DUMC-00176-00-2 | None | None | None |
| FHCRC-137500 | None | None | None |
| NCI-G99-1548 | None | None | None |
| CHNMC-02118 | None | None | None |
| MSKCC-03-058 | None | None | None |