Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2026-01-02 @ 10:42 AM
Study NCT ID:
NCT00038857
Status:
COMPLETED
Last Update Posted:
2012-08-10
First Post:
2002-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Megadose CD34 Selected Progenitor Cells for Transplantation in Patients With Advanced Hematological Malignant Diseases
Sponsor:
M.D. Anderson Cancer Center
Organization:
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 donor's platelet count falls below 75,000. 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 donor's platelet count falls below 75,000. 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:
False
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?: