Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 6:29 AM
Study NCT ID:
NCT00109993
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2005-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Campath-1H + FK506 and Methylprednisolone for GVHD
Sponsor:
Case Comprehensive Cancer Center
Organization:
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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA043703 | NIH | None | https://reporter.nih.gov/quic… | View |
| CASE-CWRU-1Z04 | OTHER | Case Comprehensive Cancer Center | View | |
| CWRU-060419 | None | None | View | |
| CASE-1Z04 | OTHER | Case Comprehensive Cancer Center | View |