Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333190
Status:
COMPLETED
Last Update Posted:
2012-03-16
First Post:
2006-05-25
Brief Title:
CD8 T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
CD8 T Cell Depletion as Graft Versus Host Disease Prophylaxis After HLA-Matched Unrelated Donor 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 trial is to determine if selectively removing only a small subset of T cells called CD8 T cells is safe and if it can reduce the risk of graft versus host disease GVHD without losing the anti-cancer effects
Detailed Description:
The patient will be admitted to the hospital once a good donor is found for chemotherapy and stem cell transplant The patient will remain in the hospital for 8 days and will receive two chemotherapy drugs fludarabine and Busulfex intravenously once each day for 4 days
On the third day after the patient has finished chemotherapy the donor cells should arrive at Dana-Farber Cancer Institute and the lab will remove CD8 cells Then the product will be given to the patient through a central line If there are not enough stem cells in the donor product then the CD8 cells will not be taken out and the patient will get the whole product
Just before and after the transplant the patient will also take tacrolimus and methotrexate to help prevent GVHD Tacrolimus is a pill that will be taken orally two times a day Methotrexate is a chemotherapy drug that is given intravenously on days 1 3 and 6 after the transplant In addition to the these drugs participants will also take antibiotics to prevent infection and Filgrastim G-CSF neupogen until their white blood cell counts are better
After the stem cell infusion check-ups and blood tests will be performed at least once a week for 1 month At about one month a bone marrow biopsy to look for the donors cells in the participants bone marrow will be performed After the 1-month evaluation the patient will be seen at least every 2 weeks with another bone marrow biopsy at 3-4 months after the transplant
After the patient is past 100 days since transplant they will be followed in the clinic and have blood work done at least once a month until 6 months post transplant
The trial will end at 6 months after the transplant but patients will be tracked for the rest of their life to look at long-term effects of this transplant
On the third day after the patient has finished chemotherapy the donor cells should arrive at Dana-Farber Cancer Institute and the lab will remove CD8 cells Then the product will be given to the patient through a central line If there are not enough stem cells in the donor product then the CD8 cells will not be taken out and the patient will get the whole product
Just before and after the transplant the patient will also take tacrolimus and methotrexate to help prevent GVHD Tacrolimus is a pill that will be taken orally two times a day Methotrexate is a chemotherapy drug that is given intravenously on days 1 3 and 6 after the transplant In addition to the these drugs participants will also take antibiotics to prevent infection and Filgrastim G-CSF neupogen until their white blood cell counts are better
After the stem cell infusion check-ups and blood tests will be performed at least once a week for 1 month At about one month a bone marrow biopsy to look for the donors cells in the participants bone marrow will be performed After the 1-month evaluation the patient will be seen at least every 2 weeks with another bone marrow biopsy at 3-4 months after the transplant
After the patient is past 100 days since transplant they will be followed in the clinic and have blood work done at least once a month until 6 months post transplant
The trial will end at 6 months after the transplant but patients will be tracked for the rest of their life to look at long-term effects of this 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