Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089037
Status:
COMPLETED
Last Update Posted:
2011-07-15
First Post:
2004-08-04
Brief Title:
Sirolimus Tacrolimus and Methotrexate in Preventing Acute Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplantation
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase III Study of Sirolimus in Addition to Tacrolimus and Methotrexate for the Prevention of Acute-Graft-Versus-Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplantation From Unrelated Donors
Status:
COMPLETED
Status Verified Date:
2011-07
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 Sirolimus tacrolimus and methotrexate may be effective in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation
PURPOSE This phase III trial is studying the side effects of sirolimus when given together with tacrolimus and methotrexate and to see how well they work in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation for hematologic cancer
PURPOSE This phase III trial is studying the side effects of sirolimus when given together with tacrolimus and methotrexate and to see how well they work in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation for hematologic cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety and efficacy of sirolimus when administered with tacrolimus and methotrexate for the prevention of acute graft-versus-host disease GVHD in patients with hematological malignancies undergoing hematopoietic stem cell transplantation from unrelated donors
Secondary
Determine the absorption and pharmacokinetics of sirolimus in patients treated with this regimen
Correlate sirolimus blood concentration with prevention of GVHD or toxicity in patients treated with this regimen
Determine the severity of post-transplantation mucositis in patients treated with this regimen
OUTLINE This is a nonrandomized open-label pilot study
Patients receive oral sirolimus once daily on days -3 to 175 and tacrolimus IV continuously beginning on day -3 and continuing until the patient is able to tolerate food and then orally twice daily until day 175 Patients also receive methotrexate IV on days 1 3 6 and 11 Treatment continues in the absence of acute graft-vs-host disease or unacceptable toxicity
Patients are followed for 5 years
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 3 years
Primary
Determine the safety and efficacy of sirolimus when administered with tacrolimus and methotrexate for the prevention of acute graft-versus-host disease GVHD in patients with hematological malignancies undergoing hematopoietic stem cell transplantation from unrelated donors
Secondary
Determine the absorption and pharmacokinetics of sirolimus in patients treated with this regimen
Correlate sirolimus blood concentration with prevention of GVHD or toxicity in patients treated with this regimen
Determine the severity of post-transplantation mucositis in patients treated with this regimen
OUTLINE This is a nonrandomized open-label pilot study
Patients receive oral sirolimus once daily on days -3 to 175 and tacrolimus IV continuously beginning on day -3 and continuing until the patient is able to tolerate food and then orally twice daily until day 175 Patients also receive methotrexate IV on days 1 3 6 and 11 Treatment continues in the absence of acute graft-vs-host disease or unacceptable toxicity
Patients are followed for 5 years
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 3 years
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 |
|---|---|---|---|
| CDR0000378004 | REGISTRY | PDQ | None |
| FHCRC-181100 | None | None | None |