Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146614
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2005-09-06
Brief Title:
Tacrolimus Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Tacrolimus Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2012-03
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 determine if the incidence of Graft vs Host Disease GVHD after non-myeloablative transplantation can be reduced by using a combination of three immune suppressive medication sirolimus tacrolimus and methotrexate
Detailed Description:
Patients will be admitted to the hospital and receive chemotherapy and stem cell transplantSCT The total duration of hospitalization for the procedure is approximately 8 days Once admitted the patient will receive fludarabine daily for 4 days busulfex once daily for 4 days Two days after chemotherapy has ended the patient will receive the infusion of donor cells
Just prior to the transplant and following the transplant patients will receive sirolimus orally tacrolimus orally and low doses of methotrexate chemotherapy Methotrexate will be given on days 13 and 6 after transplant
Sirolimus will be tapered beginning week 9 after transplant if there is no evidence of GVHD and will be eliminated on week 26 if clinically feasible
Tacrolimus will be tapered beginning week 9 after transplant if there is no evidence of GVHD and will be eliminated on week 26 if clinically feasible
Patients will also receive medication to help prevent possible infection
After stem cell infusion patients will be examined and have blood tests weekly for 1 month At the 1 month visit a bone marrow biopsy will performed looking for evidence of donor cells in the bone marrow After the one month evaluation the patient will be examined every 2 weeks and a repeat bone marrow performed 3-4 months after transplant
Just prior to the transplant and following the transplant patients will receive sirolimus orally tacrolimus orally and low doses of methotrexate chemotherapy Methotrexate will be given on days 13 and 6 after transplant
Sirolimus will be tapered beginning week 9 after transplant if there is no evidence of GVHD and will be eliminated on week 26 if clinically feasible
Tacrolimus will be tapered beginning week 9 after transplant if there is no evidence of GVHD and will be eliminated on week 26 if clinically feasible
Patients will also receive medication to help prevent possible infection
After stem cell infusion patients will be examined and have blood tests weekly for 1 month At the 1 month visit a bone marrow biopsy will performed looking for evidence of donor cells in the bone marrow After the one month evaluation the patient will be examined every 2 weeks and a repeat bone marrow performed 3-4 months after transplant
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