Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410657
Status:
COMPLETED
Last Update Posted:
2010-05-14
First Post:
2006-12-11
Brief Title:
Alemtuzumab and Glucocorticoids in Treating Newly Diagnosed Acute Graft-Versus-Host Disease in Patients Who Have Undergone a Donor Stem Cell Transplant
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase II Study to Evaluate Low-Dose Alemtuzumab as a Glucocorticoid-Sparing Agent for Initial Systemic Treatment of Acute Graft-Versus-Host Disease
Status:
COMPLETED
Status Verified Date:
2010-05
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 and glucocorticoids such as prednisone or methylprednisolone may be an effective treatment for acute graft-versus-host disease caused by a donor stem cell transplant
PURPOSE This phase II trial is studying how well giving alemtuzumab together with glucocorticoids works in treating newly diagnosed 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 glucocorticoids works in treating newly diagnosed acute graft-versus-host disease in patients who have undergone donor stem cell transplant
Detailed Description:
OBJECTIVES
Determine whether the administration of low-dose alemtuzumab at the onset of acute graft-versus-host disease can accelerate withdrawal of glucocorticoids and decrease nonrelapsing mortality in patients who have undergone myeloablative allogeneic stem cell transplantation
OUTLINE This is an open-label nonrandomized study
Within 72 hours of beginning glucocorticoid therapy patients receive alemtuzumab IV over at least 2 hours on days 1 and 2 If graft-versus-host disease GVHD responds well during days 1-14 but returns between days 28 and 56 patients are eligible to receive 2 additional doses of alemtuzumab
Patients receive glucocorticoid therapy comprising methylprednisolone IV or oral prednisone daily until objective evidence of improvement in manifestations of GVHD Patients with resolved or significantly improved GVHD receive treatment until day 10 followed by an accelerated taper until day 72 if no flare up of GVHD occurs during the glucocorticoid taper Patients with recurrent or progressive GVHD during the accelerated taper are treated for 5-7 days before resuming a less rapid taper Patients with no improvement may receive secondary therapy with alternative immunosuppressive medications at the discretion of the managing physician Treatment continues in the absence of progressive GVHD of at least 3 days duration during days 2-10 persisting GVHD without improvement between days 10-14 recurrent or progressive GVHD after day 10 that does not respond within 3 days to topical immunosuppressive therapy andor an increase in the systemic glucocorticoid dose by two taper steps or unacceptable toxicity
Patients undergo blood collection at baseline and then periodically during study treatment for pharmacokinetics and quantification of viral loads for human herpes virus 6 adenovirus Epstein-Barr virus and cytomegalovirus Samples are also examined by flow cytometry for B- and T-cell quantification at baseline periodically during study treatment and at 1 year after transplantation
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 53 patients will be accrued for this study
Determine whether the administration of low-dose alemtuzumab at the onset of acute graft-versus-host disease can accelerate withdrawal of glucocorticoids and decrease nonrelapsing mortality in patients who have undergone myeloablative allogeneic stem cell transplantation
OUTLINE This is an open-label nonrandomized study
Within 72 hours of beginning glucocorticoid therapy patients receive alemtuzumab IV over at least 2 hours on days 1 and 2 If graft-versus-host disease GVHD responds well during days 1-14 but returns between days 28 and 56 patients are eligible to receive 2 additional doses of alemtuzumab
Patients receive glucocorticoid therapy comprising methylprednisolone IV or oral prednisone daily until objective evidence of improvement in manifestations of GVHD Patients with resolved or significantly improved GVHD receive treatment until day 10 followed by an accelerated taper until day 72 if no flare up of GVHD occurs during the glucocorticoid taper Patients with recurrent or progressive GVHD during the accelerated taper are treated for 5-7 days before resuming a less rapid taper Patients with no improvement may receive secondary therapy with alternative immunosuppressive medications at the discretion of the managing physician Treatment continues in the absence of progressive GVHD of at least 3 days duration during days 2-10 persisting GVHD without improvement between days 10-14 recurrent or progressive GVHD after day 10 that does not respond within 3 days to topical immunosuppressive therapy andor an increase in the systemic glucocorticoid dose by two taper steps or unacceptable toxicity
Patients undergo blood collection at baseline and then periodically during study treatment for pharmacokinetics and quantification of viral loads for human herpes virus 6 adenovirus Epstein-Barr virus and cytomegalovirus Samples are also examined by flow cytometry for B- and T-cell quantification at baseline periodically during study treatment and at 1 year after transplantation
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 53 patients 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 |
|---|---|---|---|
| CDR0000523371 | REGISTRY | PDQ | None |
| FHCRC-209600 | None | None | None |