Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144430
Status:
COMPLETED
Last Update Posted:
2009-02-03
First Post:
2005-08-31
Brief Title:
Pentostatin for High Risk and Refractory Chronic Graft Versus Host Disease in Children
Sponsor:
Ann Robert H Lurie Childrens Hospital of Chicago
Organization:
Ann Robert H Lurie Childrens Hospital of Chicago
Study Overview
Official Title:
A Phase II Study of Pentostatin For the Treatment of High Risk or Refractory Chronic GVHD in Children
Status:
COMPLETED
Status Verified Date:
2009-02
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:
This is a multicenter trial through the Pediatric Blood and Marrow Transplant Consortium
The Primary hypothesis of this study is that because of its effect as a potent immunosuppressive agent targeting lymphocytes pentostatin will show a sustained response in pediatric subjects with severe chronic GVHD Secondary hypotheses include that the infection and toxicity rate of pentostatin in this setting will be acceptable given its lack of severe myelosuppression and subjects with refractory chronic GVHD will have significant QOL impairment and symptomatology These may change as subjects are being treated for their chronic GVHD with pentostatin
The Primary hypothesis of this study is that because of its effect as a potent immunosuppressive agent targeting lymphocytes pentostatin will show a sustained response in pediatric subjects with severe chronic GVHD Secondary hypotheses include that the infection and toxicity rate of pentostatin in this setting will be acceptable given its lack of severe myelosuppression and subjects with refractory chronic GVHD will have significant QOL impairment and symptomatology These may change as subjects are being treated for their chronic GVHD with pentostatin
Detailed Description:
To participate in this study subjects must have diagnosed chronic Graft versus Host Disease that is refractory to therapy or that is considered high risk ie low platelet count progressive onset and greater than 50 of body surface area affected Subjects must have not failed more than 2 immunosuppressive regimens in order to be considered for this trial Eligible subjects will receive intravenous pentostatin every 2 weeks for 24 weeks If the subject has had a complete response the therapy will end at 24 weeks If the subject has had a partial or mixed response or stable disease they will continue on study receiving pentostatin for 52 weeks
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