Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282282
Status:
COMPLETED
Last Update Posted:
2014-05-12
First Post:
2006-01-24
Brief Title:
Tacrolimus and Sirolimus as Prophylaxis After Allogenic Non-myeloablative Peripheral Blood Stem Cell Transplantation
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Tacrolimus and Sirolimus as Graft Versus Host Disease Prophylaxis After Allogeneic Non-myeloablative Peripheral Blood Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2014-03
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 extend the use of Tacrolimus and Sirolimus to determine how effective it is in preventing graft versus host disease GVHDin patients that have received non-myeloablative peripheral blood stem cell transplantation
Detailed Description:
After the screening procedures confirm that the patient is eligible to participate in the research study they will be admitted to the hospital to receive chemotherapy and stem cell transplantation SCT The duration of the hospitalization for the procedure is approximately 8 days
Patients will receive fludarabine once daily over 30 minutes intravenously for 4 days and busulfex once daily over 3 hours intravenously each day for the same 4 days
Just prior to the transplant and following the transplant the patient will receive sirolimus and tacrolimus to help prevent Graft versus Host Disease GvHD Both medications are taken orally
Patients will also take medications to help prevent possible infections eg acyclovir Filgrastim a white blood cell growth factor will be given daily in an injection under the skin starting the day after the stem cell transplant and until the patients blood counts have recovered
After the stem cell infusion the patient will be examined and have blood tests weekly for 1 month At about the 1-month visit a bone marrow biopsy andor blood tests will be performed to determine the percentage of donors cells in the blood or bone marrow These tests will be repeated at 3-4 months after transplant
At 3-4 months after the transplant patients will also have tests to reassess the response of your disease to transplant This may involve a bone marrow biopsy blood tests andor radiology studies depending upon the type of cancer
Follow-up will continue for the remainder of the patients life
Patients will receive fludarabine once daily over 30 minutes intravenously for 4 days and busulfex once daily over 3 hours intravenously each day for the same 4 days
Just prior to the transplant and following the transplant the patient will receive sirolimus and tacrolimus to help prevent Graft versus Host Disease GvHD Both medications are taken orally
Patients will also take medications to help prevent possible infections eg acyclovir Filgrastim a white blood cell growth factor will be given daily in an injection under the skin starting the day after the stem cell transplant and until the patients blood counts have recovered
After the stem cell infusion the patient will be examined and have blood tests weekly for 1 month At about the 1-month visit a bone marrow biopsy andor blood tests will be performed to determine the percentage of donors cells in the blood or bone marrow These tests will be repeated at 3-4 months after transplant
At 3-4 months after the transplant patients will also have tests to reassess the response of your disease to transplant This may involve a bone marrow biopsy blood tests andor radiology studies depending upon the type of cancer
Follow-up will continue for the remainder of the patients life
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