Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00469014
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2007-05-03
Brief Title:
Busulfan Fludarabine Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Busulfan-Fludarabine-Clofarabine With Allogeneic Stem Cell Transplantation for Advanced Refractory Acute Myeloid Leukemia Myelodysplastic Syndrome and Advanced Gleevec Refractory Chronic Myeloid Leukemia A Randomized Phase II Study
Status:
COMPLETED
Status Verified Date:
2021-01
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:
None
Brief Summary:
The goal of this clinical research study is to find the best dose of clofarabine and fludarabine that can be given with busulfan followed by an allogeneic blood stem cell transplant Researchers will study whether this combination can help to control the disease and look at the safety of this combination Researchers also want to find out if combining busulfan with clofarabine alone or combining busulfan with both fludarabine and clofarabine will improve the treatment compared with the previous standard method using busulfan and fludarabine alone
Detailed Description:
Busulfan is a chemotherapy drug that kills cancer cells by binding to DNA the genetic material of cells Clofarabine is designed to interfere with the growth and development of cancer cells Fludarabine is designed to interfere with DNA repair enzymes so that the leukemic cells cannot repair damaged DNA This may increase the likelihood of the cell dying These drugs are being given to try to kill cancerous cells and weaken your immune system in order to lower the risk of stem cell transplant rejection
If you are found to be eligible to take part in this study you will be randomly assigned as in the toss of a coin to 1 of 4 study groups Three 3 of the groups will receive busulfan fludarabine and clofarabine at different dose levels The 4th group will only receive busulfan and clofarabine As the study continues participants will be assigned using a method called adaptive randomization This method works by increasing the chances of being assigned to the group that has had the best results in the study so far You will know which group you have been assigned to
Participants will receive busulfan fludarabine andor clofarabine once a day for 4 doses You will first receive an additional low-level test dose of busulfan given by vein to check how your blood levels change over time This information will be used to decide the next dose needed to reach a target blood level of busulfan You will have a total of about 6 and 12 tablespoons of blood drawn over time to check your busulfan blood levels following one or more of the busulfan treatments Up to 11 samples of blood will be drawn to check your blood levels of busulfan during the next 11 hours following the test dose and the first high-dose busulfan treatment Each sample will require about 1 teaspoon of blood A heparin lock line will be placed in a vein to lower the number of needle sticks needed for these draws If it is not possible for these blood level tests to be performed for technical or scheduling reasons you will receive the standard fixed unchanging dose of busulfan
Clofarabine and fludarabine if applicable will be given through a central venous catheter CVC over 1 hour once a day for 4 days Busulfan will also be given through the CVC over 3 hours
If you are going to be receiving a transplant from an HLA-nonidentical or unrelated donor you will also receive thymoglobulin ATG over 4 hours on the 3 days before the transplant to further weaken your immune system to reduce the risk of rejecting of the transplant After the transplant you will receive tacrolimus methotrexate or other immunosuppressive lowering the immune system drugs in the standard manner to lower the risk of graft-vs-host disease GVHD a reaction of the donors immune cells against the recipients body
The allogeneic stem cells bone marrow or peripheral blood stem cells will also be given through the CVC You will receive the drug G-CSF filgrastim as an injection under the skin once a day starting 1 week after the transplant until your blood cell levels return to normal
Patients usually stay in the hospital for about 4 weeks after stem cell transplantation After you are released from the hospital you will continue to be monitored as an outpatient for infections and transplant-related complications for at least 100 days after the transplant
You will have blood tests about 4 tablespoons of blood and bone marrow aspirations performed at 1 3 6 and 12 months after the transplant to check if the disease is in remission has not come back Your health status will be followed with the help of your local doctor to find out if the leukemia or MDS comes back as well as to check the length of your survival
This is an investigational study All of the drugs used in this study are approved by the FDA for treatment of cancer Busulfan has been approved for use in stem cell transplantation The use of these drugs together with stem cell transplant is experimental Up to 70 patients will take part in this study All will be enrolled at the M D Anderson Cancer Center
If you are found to be eligible to take part in this study you will be randomly assigned as in the toss of a coin to 1 of 4 study groups Three 3 of the groups will receive busulfan fludarabine and clofarabine at different dose levels The 4th group will only receive busulfan and clofarabine As the study continues participants will be assigned using a method called adaptive randomization This method works by increasing the chances of being assigned to the group that has had the best results in the study so far You will know which group you have been assigned to
Participants will receive busulfan fludarabine andor clofarabine once a day for 4 doses You will first receive an additional low-level test dose of busulfan given by vein to check how your blood levels change over time This information will be used to decide the next dose needed to reach a target blood level of busulfan You will have a total of about 6 and 12 tablespoons of blood drawn over time to check your busulfan blood levels following one or more of the busulfan treatments Up to 11 samples of blood will be drawn to check your blood levels of busulfan during the next 11 hours following the test dose and the first high-dose busulfan treatment Each sample will require about 1 teaspoon of blood A heparin lock line will be placed in a vein to lower the number of needle sticks needed for these draws If it is not possible for these blood level tests to be performed for technical or scheduling reasons you will receive the standard fixed unchanging dose of busulfan
Clofarabine and fludarabine if applicable will be given through a central venous catheter CVC over 1 hour once a day for 4 days Busulfan will also be given through the CVC over 3 hours
If you are going to be receiving a transplant from an HLA-nonidentical or unrelated donor you will also receive thymoglobulin ATG over 4 hours on the 3 days before the transplant to further weaken your immune system to reduce the risk of rejecting of the transplant After the transplant you will receive tacrolimus methotrexate or other immunosuppressive lowering the immune system drugs in the standard manner to lower the risk of graft-vs-host disease GVHD a reaction of the donors immune cells against the recipients body
The allogeneic stem cells bone marrow or peripheral blood stem cells will also be given through the CVC You will receive the drug G-CSF filgrastim as an injection under the skin once a day starting 1 week after the transplant until your blood cell levels return to normal
Patients usually stay in the hospital for about 4 weeks after stem cell transplantation After you are released from the hospital you will continue to be monitored as an outpatient for infections and transplant-related complications for at least 100 days after the transplant
You will have blood tests about 4 tablespoons of blood and bone marrow aspirations performed at 1 3 6 and 12 months after the transplant to check if the disease is in remission has not come back Your health status will be followed with the help of your local doctor to find out if the leukemia or MDS comes back as well as to check the length of your survival
This is an investigational study All of the drugs used in this study are approved by the FDA for treatment of cancer Busulfan has been approved for use in stem cell transplantation The use of these drugs together with stem cell transplant is experimental Up to 70 patients will take part in this study All will be enrolled at the M D Anderson Cancer Center
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