Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446173
Status:
WITHDRAWN
Last Update Posted:
2015-08-25
First Post:
2007-03-09
Brief Title:
Autologous Stem Cell Transplants for Chronic Myelogenous Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Autologous Purged Hematopoietic Stem Cell Transplantation for Chronic Myelogenous Leukemia CML
Status:
WITHDRAWN
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
1 To study ex-vivo purging of autologous hematopoietic stem cells that will be used to support high-dose chemotherapy in patients with chronic myelogenous leukemia CML Major endpoints are neutrophil engraftment and survival
Secondary Objectives
1 To evaluate the toxicity of ex-vivo purged autologous cells when used to support high-dose chemotherapy
2 To evaluate the rate and duration of cytogenetic remissions achieved with this strategy
3 To determine the time to platelet recovery to 20000mm3
4 To determine the one-year survival rate
1 To study ex-vivo purging of autologous hematopoietic stem cells that will be used to support high-dose chemotherapy in patients with chronic myelogenous leukemia CML Major endpoints are neutrophil engraftment and survival
Secondary Objectives
1 To evaluate the toxicity of ex-vivo purged autologous cells when used to support high-dose chemotherapy
2 To evaluate the rate and duration of cytogenetic remissions achieved with this strategy
3 To determine the time to platelet recovery to 20000mm3
4 To determine the one-year survival rate
Detailed Description:
Before treatment starts you will have a complete physical exam You will have about 4 tablespoons of blood drawn for tests to check on the status of the disease to check organ functions and to check for infectious diseases hepatitis HIV etc You will have a sample of bone marrow collected To collect a bone marrow sample an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone marrow is withdrawn through a large needle You will also have heart cardiac ejection fraction and lung function tests All of these tests are being done to make sure you are eligible for this treatment
In order to access the blood in the circulation a silicone catheter small plastic tube will be placed in the collar bone area You will be under local anesthesia during this procedure If you are found to be eligible to take part in this study this catheter will be used for the collection of stem cells infusion of chemotherapy fluids electrolytes other medications and also for blood sampling for lab tests It will remain in your body for the length of the treatment between 2-5 months
Normally there are very few stem cells in the blood The majority of them are in the bone marrow To help move or mobilize the cells needed from your bone marrow to your blood you will be given chemotherapy followed by injections under the skin once a day of a drug called G-CSF and another drug called GM-CSF These injections will be given over 7-21 days The injections may be given by a nurse in the hospital in the outpatient setting or you may learn how to give them to yourself
The chemotherapy you will receive to help mobilize the stem cells is cyclophosphamide It will be given by vein over a few hours in one day This is the first step toward collecting the stem cells necessary for transplantation later on It is separate from the high-dose chemotherapy that you get after the transplant
Blood samples about 4 teaspoons each will be drawn once a day after the cyclophosphamide to check for the numbers of stem cells in your blood and to monitor for possible side effects If the number of stem cells in the blood is high enough you will go to the UTMDACC Apheresis Unit and have your peripheral blood progenitor cells PBPC or stem cells collected
The procedure to collect your cells is called leukapheresis It is similar to donating platelets to a blood bank The cells will be removed from the blood through the catheter and the remaining blood will be given back to you through the catheter This procedure is performed in a machine that processes the blood and separates the cells needed for transplantation giving the rest back to you Each leukapheresis procedure takes about 4-6 hours You will have one leukapheresis procedure a day for 1 to 5 days in a row until enough stem cells are collected for the transplant and for back-up in case of problems with the treated cells If after 5 procedures the number of cells collected is too low additional collections of cells may be needed
Some people may not be able to have enough cells collected through the blood If this is the case you may need to have bone marrow stem cells collected You will be taken to the operating room and have multiple collections of bone marrow performed The procedure will be performed while you are under general anesthesia About 1 - 15 liters of bone marrow will be collected You will be asked to donate your own blood before the procedure if possible That blood will be given back to you in the operating room Somebody elses blood may be given to you instead if you cannot donate
After enough stem cells are collected the cells will be treated in the laboratory using Gleevec imatinib mesylate followed by ex vivo culturepurging Culture-purging is a method that takes advantage of the fact that CML cells die when kept in laboratory culture in a shorter time period than normal blood cells If the cells are kept alive long enough surviving cells will be less contaminated by CML cells Imatinib mesylate will provide a chemical way of killing the CML cells since they are more toxic to CML cells than they are to normal cells The culture-purging will also use three medications called growth factors The medications being used are stem cell factor G-CSF and thrombopoietin
Busulfan and cyclophosphamide are chemotherapy drugs that are designed to kill leukemia cells However the combination will kill a significant amount of your bone marrow cells which will basically stop the production of blood components In order to restart the production the cells that were removed and treated in the lab will be given back to you autologous transplant
You will be admitted to the hospital to receive high dose chemotherapy You will be given busulfan by continuous injection using the catheter for 4 days then you will be given cyclophosphamide by a continuous injection using the catheter for 2 days You may also receive antibiotics fluids and other medications if your doctor feels it is necessary
After you receive the chemotherapy you will be given your treated bone marrow or blood stem cells back To help speed up the recovery of white blood cells you will also be given G-CSF by injection under the skin once a day until the white blood count has recovered usually 2 to 3 weeks and GM-CSF under the skin for a month You may also receive antibiotics fluids and other medications if your doctor feels it is necessary Blood tests about 4 teaspoons are repeated several times per week until blood counts are fully recovered and any side effects of the high dose therapy have resolved
You will have check-up visits 1 3 6 and 12 months after the transplant At these visits you will have bone marrow samples collected to monitor the disease response Bone marrow samples may also be collected for research at the same time points These samples will be used to determine the survival of stem cells in laboratory conditions after the transplant You will have blood collected 1- 4 tablespoons for routine blood tests
This is an investigational study Busulfan cyclophosphamide G-CSF and GM-CSF are commercially available drugs Up to 48 patients will take part in this study All will be treated at M D Anderson
In order to access the blood in the circulation a silicone catheter small plastic tube will be placed in the collar bone area You will be under local anesthesia during this procedure If you are found to be eligible to take part in this study this catheter will be used for the collection of stem cells infusion of chemotherapy fluids electrolytes other medications and also for blood sampling for lab tests It will remain in your body for the length of the treatment between 2-5 months
Normally there are very few stem cells in the blood The majority of them are in the bone marrow To help move or mobilize the cells needed from your bone marrow to your blood you will be given chemotherapy followed by injections under the skin once a day of a drug called G-CSF and another drug called GM-CSF These injections will be given over 7-21 days The injections may be given by a nurse in the hospital in the outpatient setting or you may learn how to give them to yourself
The chemotherapy you will receive to help mobilize the stem cells is cyclophosphamide It will be given by vein over a few hours in one day This is the first step toward collecting the stem cells necessary for transplantation later on It is separate from the high-dose chemotherapy that you get after the transplant
Blood samples about 4 teaspoons each will be drawn once a day after the cyclophosphamide to check for the numbers of stem cells in your blood and to monitor for possible side effects If the number of stem cells in the blood is high enough you will go to the UTMDACC Apheresis Unit and have your peripheral blood progenitor cells PBPC or stem cells collected
The procedure to collect your cells is called leukapheresis It is similar to donating platelets to a blood bank The cells will be removed from the blood through the catheter and the remaining blood will be given back to you through the catheter This procedure is performed in a machine that processes the blood and separates the cells needed for transplantation giving the rest back to you Each leukapheresis procedure takes about 4-6 hours You will have one leukapheresis procedure a day for 1 to 5 days in a row until enough stem cells are collected for the transplant and for back-up in case of problems with the treated cells If after 5 procedures the number of cells collected is too low additional collections of cells may be needed
Some people may not be able to have enough cells collected through the blood If this is the case you may need to have bone marrow stem cells collected You will be taken to the operating room and have multiple collections of bone marrow performed The procedure will be performed while you are under general anesthesia About 1 - 15 liters of bone marrow will be collected You will be asked to donate your own blood before the procedure if possible That blood will be given back to you in the operating room Somebody elses blood may be given to you instead if you cannot donate
After enough stem cells are collected the cells will be treated in the laboratory using Gleevec imatinib mesylate followed by ex vivo culturepurging Culture-purging is a method that takes advantage of the fact that CML cells die when kept in laboratory culture in a shorter time period than normal blood cells If the cells are kept alive long enough surviving cells will be less contaminated by CML cells Imatinib mesylate will provide a chemical way of killing the CML cells since they are more toxic to CML cells than they are to normal cells The culture-purging will also use three medications called growth factors The medications being used are stem cell factor G-CSF and thrombopoietin
Busulfan and cyclophosphamide are chemotherapy drugs that are designed to kill leukemia cells However the combination will kill a significant amount of your bone marrow cells which will basically stop the production of blood components In order to restart the production the cells that were removed and treated in the lab will be given back to you autologous transplant
You will be admitted to the hospital to receive high dose chemotherapy You will be given busulfan by continuous injection using the catheter for 4 days then you will be given cyclophosphamide by a continuous injection using the catheter for 2 days You may also receive antibiotics fluids and other medications if your doctor feels it is necessary
After you receive the chemotherapy you will be given your treated bone marrow or blood stem cells back To help speed up the recovery of white blood cells you will also be given G-CSF by injection under the skin once a day until the white blood count has recovered usually 2 to 3 weeks and GM-CSF under the skin for a month You may also receive antibiotics fluids and other medications if your doctor feels it is necessary Blood tests about 4 teaspoons are repeated several times per week until blood counts are fully recovered and any side effects of the high dose therapy have resolved
You will have check-up visits 1 3 6 and 12 months after the transplant At these visits you will have bone marrow samples collected to monitor the disease response Bone marrow samples may also be collected for research at the same time points These samples will be used to determine the survival of stem cells in laboratory conditions after the transplant You will have blood collected 1- 4 tablespoons for routine blood tests
This is an investigational study Busulfan cyclophosphamide G-CSF and GM-CSF are commercially available drugs Up to 48 patients will take part in this study All will be treated 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