Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053976
Status:
COMPLETED
Last Update Posted:
2017-01-23
First Post:
2003-02-05
Brief Title:
Methylprednisolone With or Without Daclizumab in Treating Patients With Acute Graft-Versus-Host Disease
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Treatment of Acute Graft vs Host Disease With Steroids Plus Daclizumab Zenapax or Placebo
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:
The purpose of this study is to compare the effects of IL2 receptor antibody also known as Daclizumab or Zenapax and corticosteroids alone for control of GVHD Treatment with corticosteroids is standard care for GVHD This research is being done because the investigators do not know whether addition of this new medication to standard corticosteroid therapy improves response rates Since Zenapax binds to a type of cell which is thought to cause GVHD and possibly inactivates them investigators have reason to believe that addition of Zenapax night result in better control of GVHD This study will determine whether the addition of another medication Zenapax will be more effective than steroids alone in suppressing GVHD and improving symptoms of GVHD
Daclizumab Zenapax is approved by the Food and Drug Administration FDA for use in patient with kidney transplant to help prevent graft rejection This medication has been used in bone marrow transplant patients to treat GVHD
Daclizumab Zenapax is approved by the Food and Drug Administration FDA for use in patient with kidney transplant to help prevent graft rejection This medication has been used in bone marrow transplant patients to treat GVHD
Detailed Description:
GVHD occurs when the donors immune system recognizes a patients body as foreign and reacts against it GVHD may result in skin rashes and blistering liver inflammation and gastrointestinal problems including nausea vomiting diarrhea and bleeding Mild GVHD may be treated with topical medications applied to the skin More severe GVHD requires medications given intravenously by vein or taken by mouth Steroids are usually given first to treat GVHD but only 40 of people respond to this alone
OBJECTIVES
Compare response to treatment in patients with acute graft-versus-host disease GVHD treated with methylprednisolone with or without daclizumab
Compare differences in total methylprednisolone dose and complications in patients treated with these regimens
Compare mortality days of antibiotics and antifungal therapy and required hospital days within the first 100 days for patients treated with these regimens
Compare overall survival and incidence of chronic GVHD at 1 year in patients treated with these regimens
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are stratified according to prior graft-versus-host disease GVHD prophylaxis immunosuppressive therapy vs T-cell depletion GVHD organ manifestation skin only vs other donor type 66 matched sibling vs other and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive methylprednisolone or equivalent corticosteroid IV or orally and daclizumab IV over 15 minutes on days 0 3 7 14 and then weekly as indicated until day 100
Arm II Patients receive methylprednisolone or equivalent corticosteroid as in arm I and placebo
Patients are followed at 1 year and then annually thereafter
OBJECTIVES
Compare response to treatment in patients with acute graft-versus-host disease GVHD treated with methylprednisolone with or without daclizumab
Compare differences in total methylprednisolone dose and complications in patients treated with these regimens
Compare mortality days of antibiotics and antifungal therapy and required hospital days within the first 100 days for patients treated with these regimens
Compare overall survival and incidence of chronic GVHD at 1 year in patients treated with these regimens
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are stratified according to prior graft-versus-host disease GVHD prophylaxis immunosuppressive therapy vs T-cell depletion GVHD organ manifestation skin only vs other donor type 66 matched sibling vs other and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive methylprednisolone or equivalent corticosteroid IV or orally and daclizumab IV over 15 minutes on days 0 3 7 14 and then weekly as indicated until day 100
Arm II Patients receive methylprednisolone or equivalent corticosteroid as in arm I and placebo
Patients are followed at 1 year and then annually thereafter
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 |
|---|---|---|---|
| ROCHE-RPCI-DS-0218 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006516 |
| P30CA016056 | NIH | None | None |
| P30CA006516 | NIH | None | None |
| RPCI-DS-0218 | None | None | None |