Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109993
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2005-05-03
Brief Title:
Campath-1H FK506 and Methylprednisolone for GVHD
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Clinical Trial Incorporating Alemtuzumab Campath-1H in Combination With FK506 and Methylprednisolone for Treatment of Severe Acute Graft vs Host Disease
Status:
COMPLETED
Status Verified Date:
2010-06
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 Alemtuzumab tacrolimus and methylprednisolone may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant
PURPOSE This phase II trial is studying how well giving alemtuzumab together with tacrolimus and methylprednisolone works in treating acute graft-versus-host disease in patients who have undergone donor stem cell transplant
PURPOSE This phase II trial is studying how well giving alemtuzumab together with tacrolimus and methylprednisolone works in treating acute graft-versus-host disease in patients who have undergone donor stem cell transplant
Detailed Description:
OBJECTIVES
Primary
Determine the 4-week rate of complete response in patients with severe acute graft-vs-host disease GVHD treated with alemtuzumab tacrolimus and methylprednisolone within 100 days after undergoing allogeneic stem cell transplantation
Secondary
Determine the best response at 4 and 12 weeks in patients treated with this regimen
Determine 6-month survival of patients treated with this regimen
Determine the rate of infectious complications in patients treated with this regimen
Determine rate of chronic GVHD in patients treated with this regimen
OUTLINE This is an open-label single-blind multicenter study
Patients receive methylprednisolone IV on days 1-3 and then orally or IV on days 4-14 tacrolimus IV continuously on days 1-7 and then orally once or twice daily on days 8-180 followed by a taper in the absence of chronic graft-vs-host disease and alemtuzumab IV over 2 hours on days 4-6 18 and 32 Treatment continues in the absence of unacceptable toxicity or the development of serious infection
After completion of study treatment patients are followed at 2 and 4 weeks
PROJECTED ACCRUAL A total of 9-34 patients will be accrued for this study within 8-12 months
Primary
Determine the 4-week rate of complete response in patients with severe acute graft-vs-host disease GVHD treated with alemtuzumab tacrolimus and methylprednisolone within 100 days after undergoing allogeneic stem cell transplantation
Secondary
Determine the best response at 4 and 12 weeks in patients treated with this regimen
Determine 6-month survival of patients treated with this regimen
Determine the rate of infectious complications in patients treated with this regimen
Determine rate of chronic GVHD in patients treated with this regimen
OUTLINE This is an open-label single-blind multicenter study
Patients receive methylprednisolone IV on days 1-3 and then orally or IV on days 4-14 tacrolimus IV continuously on days 1-7 and then orally once or twice daily on days 8-180 followed by a taper in the absence of chronic graft-vs-host disease and alemtuzumab IV over 2 hours on days 4-6 18 and 32 Treatment continues in the absence of unacceptable toxicity or the development of serious infection
After completion of study treatment patients are followed at 2 and 4 weeks
PROJECTED ACCRUAL A total of 9-34 patients will be accrued for this study within 8-12 months
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 |
|---|---|---|---|
| P30CA043703 | NIH | None | None |
| CASE-CWRU-1Z04 | OTHER | None | None |
| CWRU-060419 | None | None | None |
| CASE-1Z04 | OTHER | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |