Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368355
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2005-09-21
Brief Title:
T Cell Depletion for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
CD-34 Selection for Ex-vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts Receiving Intensive Conditioning
Status:
COMPLETED
Status Verified Date:
2020-01
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:
MOHEL
Brief Summary:
Subjects are being asked to participate in this study because treatment of their disease requires them to receive a stem cell transplant Stem cells or mother cells are the source of normal blood cells and lead to recovery of blood counts after bone marrow transplantation BMT Unfortunately there is not a perfectly matched stem cell donor like a sister or brother and the subjects disease is considered rapidly progressive and does not permit enough time to identify another donor like someone from a registry list that is not their relative We have however identified a close relative of the subjects whose stem cells are not a perfect match but can be used However with this type of donor there is typically an increased risk of developing graft-versus-host disease GVHD a high rate of transplant failure and a longer delay in the recovery of the immune system
GVHD is a serious and sometimes fatal side effect of stem cell transplant GVHD occurs when the new donor cells graft recognizes that the body tissues of the patient host are different from those of the donor When this happens cells in the graft may attack the host organs primarily the skin liver and intestines The number of occurrences and harshness of severe GVHD depends on several factors including the degree of genetic differences between the donor and recipient the intensity of the pre-treatment conditioning regimen the quantity of transplanted cells and the recipients age In recipients of mismatched family member or matched unrelated donor stem cell transplants there is a greater risk of GVHD so that 70-90 of recipients of unchanged marrow will develop severe GVHD which could include symptoms such as marked diarrhea liver failure or even death
In an effort to lower the occurrences and severity of graft-versus-host disease in patients and to lower the rate of transplant failure we would like to specially treat the donors blood cells to remove cells that are most likely to attack the patients tissues This will occur in combination with intense conditioning treatment that the patient will receive before the transplant
GVHD is a serious and sometimes fatal side effect of stem cell transplant GVHD occurs when the new donor cells graft recognizes that the body tissues of the patient host are different from those of the donor When this happens cells in the graft may attack the host organs primarily the skin liver and intestines The number of occurrences and harshness of severe GVHD depends on several factors including the degree of genetic differences between the donor and recipient the intensity of the pre-treatment conditioning regimen the quantity of transplanted cells and the recipients age In recipients of mismatched family member or matched unrelated donor stem cell transplants there is a greater risk of GVHD so that 70-90 of recipients of unchanged marrow will develop severe GVHD which could include symptoms such as marked diarrhea liver failure or even death
In an effort to lower the occurrences and severity of graft-versus-host disease in patients and to lower the rate of transplant failure we would like to specially treat the donors blood cells to remove cells that are most likely to attack the patients tissues This will occur in combination with intense conditioning treatment that the patient will receive before the transplant
Detailed Description:
To participate in this study the subject will need to have a central line a thin plastic catheter or tube that is placed during surgery into one of the large veins in the neck or chest
Also before treatment can begin we will test the subjects blood for viruses which can cause problems after the transplant
Before treatment can begin stem cells will be collected from the donor that has been selected as the best match for the subject White blood cells will be collected from the donor The cells will then be mixed with a special protein called a CD34 antibody that binds to the stem cells which will then be separated out from the white blood cells by a special machine called a CLINIMACs CD34 Reagent System in the laboratory This is an investigational and experimental device which is not approved by the FDA Although this device is not approved for use in this country it has been in use for years and is approved in other countries The stem cells will be collected and frozen before we start to give chemotherapy
TREATMENT PLAN
To prepare the subjects body for transplantation the subject will be given high dose chemotherapy also called a conditioning treatment for 8 days prior to the transplant as follows
The subject will be given a drug called Ara-C in high doses through the central line every 12 hours starting 8 days before transplant called day - 8 until 5 days before transplant called day - 5 Starting one day after receiving the first Ara-C dose day - 7 we will add a drug called cyclophosphamide once a day to the treatment for the next two days This will be given in high doses also through the central line Also on day - 7 we will add a drug called MESNA MESNA is used to decrease the side effects caused by cyclophosphamide After the medication treatment is finished day - 4 radiation treatment will be given to the entire body twice a day for 4 days The chemotherapy and radiation treatment will last 8 days If the subject has abnormal cells in the spinal fluid 6 extra daily doses of radiation treatment may be given to the head This would be done before any of the drugs are given and before the subject is admitted for transplant
NOTE Depending on the subjects health status the doctor may decide the subject should not receive Ara-C If this is a possibility the doctor will discuss this with the subject
On the second day of radiation day -3 the subject will receive CAMPATH-1H as a daily 4-hour IV intravenous by vein The subject will receive this infusion once a day for a total of three days CAMPATH 1H is a special type of protein called an antibody that works against certain types of blood cells CAMPATH 1H is important because it stays active in the body for a long time after infusion which means it may work longer at preventing GVHD symptoms
The day after the radiation treatment is completed day 0 the subject will receive the specially selected donor stem cells Once in the bloodstream the cells will go to the bone marrow and should begin to grow If the subject is at risk for developing GVHD or if the subject begins to develop GVHD the doctor will prescribe medicines to help prevent or treat this side effect The doctor will describe these medicines at that time
To learn more about the way the new cells are growing blood will be taken for research purposes at approximately 3 months 6 months 9 months and a year after the transplant On day 100 the subject will have the same testsevaluations the subject has been experiencing since the transplant however the subject will also have a bone marrow aspirate we take a sample of bone marrow to evaluate the disease and GVHD status For patients who do not develop GVHD they may have an additional bone marrow aspirate on day 180 about 2 months after the previous one
After day 365 the subject will be asked to return to the clinic once a year for evaluations These evaluations will be similar to the ones the subject had on day 100
Also before treatment can begin we will test the subjects blood for viruses which can cause problems after the transplant
Before treatment can begin stem cells will be collected from the donor that has been selected as the best match for the subject White blood cells will be collected from the donor The cells will then be mixed with a special protein called a CD34 antibody that binds to the stem cells which will then be separated out from the white blood cells by a special machine called a CLINIMACs CD34 Reagent System in the laboratory This is an investigational and experimental device which is not approved by the FDA Although this device is not approved for use in this country it has been in use for years and is approved in other countries The stem cells will be collected and frozen before we start to give chemotherapy
TREATMENT PLAN
To prepare the subjects body for transplantation the subject will be given high dose chemotherapy also called a conditioning treatment for 8 days prior to the transplant as follows
The subject will be given a drug called Ara-C in high doses through the central line every 12 hours starting 8 days before transplant called day - 8 until 5 days before transplant called day - 5 Starting one day after receiving the first Ara-C dose day - 7 we will add a drug called cyclophosphamide once a day to the treatment for the next two days This will be given in high doses also through the central line Also on day - 7 we will add a drug called MESNA MESNA is used to decrease the side effects caused by cyclophosphamide After the medication treatment is finished day - 4 radiation treatment will be given to the entire body twice a day for 4 days The chemotherapy and radiation treatment will last 8 days If the subject has abnormal cells in the spinal fluid 6 extra daily doses of radiation treatment may be given to the head This would be done before any of the drugs are given and before the subject is admitted for transplant
NOTE Depending on the subjects health status the doctor may decide the subject should not receive Ara-C If this is a possibility the doctor will discuss this with the subject
On the second day of radiation day -3 the subject will receive CAMPATH-1H as a daily 4-hour IV intravenous by vein The subject will receive this infusion once a day for a total of three days CAMPATH 1H is a special type of protein called an antibody that works against certain types of blood cells CAMPATH 1H is important because it stays active in the body for a long time after infusion which means it may work longer at preventing GVHD symptoms
The day after the radiation treatment is completed day 0 the subject will receive the specially selected donor stem cells Once in the bloodstream the cells will go to the bone marrow and should begin to grow If the subject is at risk for developing GVHD or if the subject begins to develop GVHD the doctor will prescribe medicines to help prevent or treat this side effect The doctor will describe these medicines at that time
To learn more about the way the new cells are growing blood will be taken for research purposes at approximately 3 months 6 months 9 months and a year after the transplant On day 100 the subject will have the same testsevaluations the subject has been experiencing since the transplant however the subject will also have a bone marrow aspirate we take a sample of bone marrow to evaluate the disease and GVHD status For patients who do not develop GVHD they may have an additional bone marrow aspirate on day 180 about 2 months after the previous one
After day 365 the subject will be asked to return to the clinic once a year for evaluations These evaluations will be similar to the ones the subject had on day 100
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