Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00357084
Status:
COMPLETED
Last Update Posted:
2010-09-14
First Post:
2006-07-26
Brief Title:
Methotrexate and Glucocorticoids in Treating Patients With Newly Diagnosed Acute Graft-Versus-Host Disease After Donor Stem Cell Transplant
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase II Study to Evaluate Efficacy and Tolerability of Methotrexate in Combination With Glucocorticoids for the Treatment of Newly Diagnosed Acute Graft-Versus-Host Disease After Nonmyeloablative Hematopoietic Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2010-09
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 Methotrexate and glucocorticoid therapy 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 methotrexate together with glucocorticoids works in treating patients with newly diagnosed acute graft-versus-host disease after donor stem cell transplant
PURPOSE This phase II trial is studying how well giving methotrexate together with glucocorticoids works in treating patients with newly diagnosed acute graft-versus-host disease after donor stem cell transplant
Detailed Description:
OBJECTIVES
Determine within the limits of a phase II study whether low-dose methotrexate can accelerate withdrawal of glucocorticoids and decrease nonrelapsing mortality in patients with newly diagnosed acute graft-versus-host disease GVHD who have undergone nonmyeloablative allogeneic hematopoietic stem cell transplantation HSCT
Determine the tolerability of low-dose methotrexate and glucocorticoids in treating newly diagnosed acute GVHD in these patients
OUTLINE This is a cohort study Patients receive concurrent low-dose methotrexate and a glucocorticoid for treatment of acute graft-versus-host disease GVHD
Patients receive the first dose of methotrexate IV 12 hours before initiation of glucocorticoid treatment if glucocorticoid treatment has not been initiated and the second dose 72 hours after dose 1 Patients then receive subsequent doses of methotrexate IV or orally once weekly for up to 1 year until resolution of GVHD in the absence of recurrent malignancy refractory or chronic GVHD administration of secondary treatment for GVHD or unacceptable toxicity
NOTE Treatment with low-dose MTX may continue beyond 1 year at the discretion of the managing physician
Patients receive glucocorticoid therapy comprising prednisone or methylprednisolone IV twice daily until objective evidence of improvement in GVHD manifestation Patients with resolved or significantly improved GVHD receive treatment for 10 days followed by an accelerated taper for a total of 72 days of treatment in case of no flare up of GVHD during the glucocorticoid taper Patients with exacerbation or recurrence of GVHD during the accelerated taper are treated for 1 week before resuming a less rapid taper Patients who develop GVHD progression or primary refractory GVHD may receive secondary systemic therapy at the discretion of the managing physician
After completion of study treatment patients are followed at 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 53 patients will be accrued for this study
Determine within the limits of a phase II study whether low-dose methotrexate can accelerate withdrawal of glucocorticoids and decrease nonrelapsing mortality in patients with newly diagnosed acute graft-versus-host disease GVHD who have undergone nonmyeloablative allogeneic hematopoietic stem cell transplantation HSCT
Determine the tolerability of low-dose methotrexate and glucocorticoids in treating newly diagnosed acute GVHD in these patients
OUTLINE This is a cohort study Patients receive concurrent low-dose methotrexate and a glucocorticoid for treatment of acute graft-versus-host disease GVHD
Patients receive the first dose of methotrexate IV 12 hours before initiation of glucocorticoid treatment if glucocorticoid treatment has not been initiated and the second dose 72 hours after dose 1 Patients then receive subsequent doses of methotrexate IV or orally once weekly for up to 1 year until resolution of GVHD in the absence of recurrent malignancy refractory or chronic GVHD administration of secondary treatment for GVHD or unacceptable toxicity
NOTE Treatment with low-dose MTX may continue beyond 1 year at the discretion of the managing physician
Patients receive glucocorticoid therapy comprising prednisone or methylprednisolone IV twice daily until objective evidence of improvement in GVHD manifestation Patients with resolved or significantly improved GVHD receive treatment for 10 days followed by an accelerated taper for a total of 72 days of treatment in case of no flare up of GVHD during the glucocorticoid taper Patients with exacerbation or recurrence of GVHD during the accelerated taper are treated for 1 week before resuming a less rapid taper Patients who develop GVHD progression or primary refractory GVHD may receive secondary systemic therapy at the discretion of the managing physician
After completion of study treatment patients are followed at 1 year and then annually thereafter
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 |
|---|---|---|---|
| CDR0000488486 | REGISTRY | PDQ | None |
| FHCRC-197800 | None | None | None |