Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003894
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
1999-11-01
Brief Title:
Thalidomide in Treating Patients With Chronic Graft-Versus-Host Disease Following Bone Marrow Transplant
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Thalidomide vs Placebo for Steroid Dependent or Refractory Chronic Graft vs Host Disease cGVHD IND 42782
Status:
COMPLETED
Status Verified Date:
2011-03
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 Thalidomide may interfere with the bodys ability to recognize transplanted bone marrow cells as foreign and may help treat patients with graft-versus-host disease
PURPOSE Randomized phase II trial to study the effectiveness of thalidomide in treating patients who have chronic graft-versus-host disease following bone marrow transplantation
PURPOSE Randomized phase II trial to study the effectiveness of thalidomide in treating patients who have chronic graft-versus-host disease following bone marrow transplantation
Detailed Description:
OBJECTIVES I Determine the efficacy of thalidomide in patients with steroid dependent or refractory chronic graft vs host disease following an allogeneic bone marrow transplant II Determine the toxicity of this regimen in these patients
OUTLINE This is a randomized study Patients are stratified according to the type of bone marrow transplant received allogeneic vs matched unrelated donor and type of chronic graft vs host disease steroid dependent vs steroid refractory Patients receive either oral thalidomide or placebo 2-4 times a day for 6 months The drug is then tapered until stopped If disease recurs the drug may be restarted for a second 6 month course The maximum duration of treatment is 18 months Patients continue on steroid therapy which is tapered during study therapy If no response is seen after 8 weeks patients may cross over to the other alternate drug Patients are followed weekly for 1 month then every month for 1 year
PROJECTED ACCRUAL A total of 36 patients 18 per arm will be accrued for this study
OUTLINE This is a randomized study Patients are stratified according to the type of bone marrow transplant received allogeneic vs matched unrelated donor and type of chronic graft vs host disease steroid dependent vs steroid refractory Patients receive either oral thalidomide or placebo 2-4 times a day for 6 months The drug is then tapered until stopped If disease recurs the drug may be restarted for a second 6 month course The maximum duration of treatment is 18 months Patients continue on steroid therapy which is tapered during study therapy If no response is seen after 8 weeks patients may cross over to the other alternate drug Patients are followed weekly for 1 month then every month for 1 year
PROJECTED ACCRUAL A total of 36 patients 18 per 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 |
|---|---|---|---|
| RPCI-RP-9809 | None | None | None |