Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038857
Status:
COMPLETED
Last Update Posted:
2012-08-10
First Post:
2002-06-05
Brief Title:
Megadose CD34 Selected Progenitor Cells for Transplantation in Patients With Advanced Hematological Malignant Diseases
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Megadose CD34 Selected Progenitor Cells for Transplantation in Patients With Advanced Hematological Malignant Diseases
Status:
COMPLETED
Status Verified Date:
2012-08
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:
Donor
This clinical study will evaluate the feasibility of a purified CD34 peripheral blood progenitor cell PBPC transplants in patients with hematological malignancies
The primary objectives of the study are to evaluate the recipient obtaining donor derived neutrophil engraftment and the incidence of acute graft versus host disease GvHD grade III-IV
Secondary objectives include assessments of recipient having donor derived platelet engraftment incidence of graft failure and chronic GvHD overall and disease free survival clinical safety and device performance of the CliniMACS CD34 selection device
This clinical study will evaluate the feasibility of a purified CD34 peripheral blood progenitor cell PBPC transplants in patients with hematological malignancies
The primary objectives of the study are to evaluate the recipient obtaining donor derived neutrophil engraftment and the incidence of acute graft versus host disease GvHD grade III-IV
Secondary objectives include assessments of recipient having donor derived platelet engraftment incidence of graft failure and chronic GvHD overall and disease free survival clinical safety and device performance of the CliniMACS CD34 selection device
Detailed Description:
Donor Description
Before taking part in this study donors will have an evaluation that is the standard for any bone marrow or blood stem cell donor These include standard blood tests an electrocardiogram EKG and a chest X-ray Donors will also be given a general health questionnaire that is given to all blood donors in the United States It should take no more than 10 minutes to complete the questionnaire
Donors in this study will receive standard mobilization therapy with daily G-CSF every 12 hours The Granulocyte colony-stimulating factor G-CSF will be given as an injection under the skin The mobilization phase starts on the first day that donors receive G-CSF and continues until the final day of the stem cell collection process leukapheresis
Donors in this study will receive Neupogen white blood cell growth factor to stimulate the immature blood cells They will receive two injections twice a day for four days On the fourth day assuming they have enough immature white blood cells researchers will start the stem cell collection process leukapheresis
The stem cell collection will go from 1 to 4 days until enough immature cells have been collected but will not be done on any day the donors platelet count falls below 75000 The stem cell is called a CD34 cell These cells will then be processed over a cell-processing machine to try to purify the immature fraction of cells and remove the T-lymphocytes that are part of the fatal graft versus host disease The T-cell is called a CD3 cell
Leukapheresis with later CD34 cell selection will start on the day when circulating CD34 count is at a high enough level Leukapheresis will continue until the appropriate count is reached If the CD3 count is too high adjustments will be made
For those donors who cannot reach the collection goal in one series of collection attempts researchers will wait until the donor recovers from the first stem cell collection and try again If the donor is unable to reach the collection goal again another attempt will be made with a different donor
The blood thinner used for the procedure will be acid citrate dextrose ACD Heparin may be substituted when clinically needed No additional blood thinners or additives should be added beyond those normally used during leukapheresis A unique identification and labeling system shall be used to track the leukapheresis product from collection to infusion
Samples will be taken from each leukapheresis product pre- and post-selection for quality analysis
This is an investigational study No more than 90 donors will take part in this study All will be enrolled at M D Anderson
Recipient Description
Before taking part in this study recipients will have standard evaluations to determine the stage of their disease These may include bone marrow aspirations and biopsies and if necessary CT scans and chest x-rays All recipients will go through cardiopulmonary evaluation
The recipients will have an allogeneic bone marrow transplant with pre-treatment of thiotepa fludarabine melphalan and antithymocyte globulin This will be followed by infusion of the peripheral blood progenitor cells
Recipients will have daily follow-up exams in the hospital Recipients will be evaluated at least one to five times per week after they leave until Day 100 After that they will have evaluations at least once every three months until about one year and then once every six months
The CliniMACS device is being provided by used of an investigational device exemption for the FDA Without the CliniMACS device this procedure would not be possible
This is an investigational study A total of 40 patients will take part in this study All will be enrolled at M D Anderson
Before taking part in this study donors will have an evaluation that is the standard for any bone marrow or blood stem cell donor These include standard blood tests an electrocardiogram EKG and a chest X-ray Donors will also be given a general health questionnaire that is given to all blood donors in the United States It should take no more than 10 minutes to complete the questionnaire
Donors in this study will receive standard mobilization therapy with daily G-CSF every 12 hours The Granulocyte colony-stimulating factor G-CSF will be given as an injection under the skin The mobilization phase starts on the first day that donors receive G-CSF and continues until the final day of the stem cell collection process leukapheresis
Donors in this study will receive Neupogen white blood cell growth factor to stimulate the immature blood cells They will receive two injections twice a day for four days On the fourth day assuming they have enough immature white blood cells researchers will start the stem cell collection process leukapheresis
The stem cell collection will go from 1 to 4 days until enough immature cells have been collected but will not be done on any day the donors platelet count falls below 75000 The stem cell is called a CD34 cell These cells will then be processed over a cell-processing machine to try to purify the immature fraction of cells and remove the T-lymphocytes that are part of the fatal graft versus host disease The T-cell is called a CD3 cell
Leukapheresis with later CD34 cell selection will start on the day when circulating CD34 count is at a high enough level Leukapheresis will continue until the appropriate count is reached If the CD3 count is too high adjustments will be made
For those donors who cannot reach the collection goal in one series of collection attempts researchers will wait until the donor recovers from the first stem cell collection and try again If the donor is unable to reach the collection goal again another attempt will be made with a different donor
The blood thinner used for the procedure will be acid citrate dextrose ACD Heparin may be substituted when clinically needed No additional blood thinners or additives should be added beyond those normally used during leukapheresis A unique identification and labeling system shall be used to track the leukapheresis product from collection to infusion
Samples will be taken from each leukapheresis product pre- and post-selection for quality analysis
This is an investigational study No more than 90 donors will take part in this study All will be enrolled at M D Anderson
Recipient Description
Before taking part in this study recipients will have standard evaluations to determine the stage of their disease These may include bone marrow aspirations and biopsies and if necessary CT scans and chest x-rays All recipients will go through cardiopulmonary evaluation
The recipients will have an allogeneic bone marrow transplant with pre-treatment of thiotepa fludarabine melphalan and antithymocyte globulin This will be followed by infusion of the peripheral blood progenitor cells
Recipients will have daily follow-up exams in the hospital Recipients will be evaluated at least one to five times per week after they leave until Day 100 After that they will have evaluations at least once every three months until about one year and then once every six months
The CliniMACS device is being provided by used of an investigational device exemption for the FDA Without the CliniMACS device this procedure would not be possible
This is an investigational study A total of 40 patients will take part in this study All will be enrolled at M D Anderson
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