Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350818
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
2006-07-07
Brief Title:
Azacitidine Maintenance Therapy After Allogeneic Bone Marrow Transplantation Allo BMT
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Azacitidine Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for AML and MDS
Status:
COMPLETED
Status Verified Date:
2012-07
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:
Primary Objective
-To determine the dose and schedule combination of 5-Azacitidine when used as maintenance treatment after allogeneic transplantation for high-risk AML MDS
Secondary Objective
-To assess the effect of treatment on survival after allogeneic transplantation for high-risk AML MDS
-To determine the dose and schedule combination of 5-Azacitidine when used as maintenance treatment after allogeneic transplantation for high-risk AML MDS
Secondary Objective
-To assess the effect of treatment on survival after allogeneic transplantation for high-risk AML MDS
Detailed Description:
Azacitidine is a drug that is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes By blocking the bad genes the tumor-fighting genes may be able to work better
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in this study You will have a complete medical history and physical exam Women who are able to have children must have a negative blood pregnancy test
If you are found to be eligible to take part in this study you will be given chemotherapy before the transplant of donor cells There are 2 major goals to giving this chemotherapy One goal is to directly kill leukemic cells The other goal is to block your ability to reject the donor cells that will be given to your for the transplantation
All participants will receive a combination of 3 chemotherapy drugs--gemtuzumab fludarabine and melphalan In order to receive gemtuzumab your bone marrow leukemia cells have to be positive for a marker called CD33 which is present in the majority of myeloid leukemias If your cells are negative for that marker the chemotherapy you receive will not include gemtuzumab Anti-thymocyte globulin ATG will be given to patients receiving stem cells from an unrelated donor or from a relative that is not fully matched with you
All chemotherapy drugs are given by vein through a silicone catheter Gemtuzumab is given 12 days before the transplant may be given as an outpatient infusion Fludarabine is given once a day for 4 days 5-2 days before the transplant and melphalan is given as a single dose 2 days before the transplant If you are receiving ATG this drug will be given in 3 doses given 3-1days before the transplant The transplant day is usually referred to as Day 0
A total of 5 bone marrow biopsies will be collected during the first year after transplantation--before the start of treatment around 1 month after transplantation and around 4 9 and 12 months after transplantation To collect a bone marrow sample an area of the hip bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle The bone marrow samples will be used primarily for disease status evaluation but researchers will also use the samples for research on the way azacitidine works
Eleven 11 blood samples 2 teaspoons each will be collected for research purposes during the 1 year of your participation in this study Samples will be collected before chemotherapy before stem cell transplantation before and after you receive 5-azacitidine for each of the 4 cycles of treatment and on the third week of the first cycle of 5-azacitidine treatment
After the blood-forming cells are collected from the donor they will be given to you by vein for your transplant Before the infusion you will receive medications such as steroids and Benadryl diphenhydramine to decrease the risk of side effects These premedications are given by vein usually 30 to 60 minutes before the transplant
You will receive several medications to help the treatment work and to help decrease the risks of infections while your immune system is weak Tacrolimus and methotrexate will be given to decrease the risk of graft-versus-host disease GVHD a problem that may occur if the donors immune cells fight your body Tacrolimus will be started 2 days before the transplant and will continue for a variable period of time eg 3-12 months or longer if you develop GVHD Tacrolimus is given by vein at first and then by mouth when patients are able to eat Methotrexate is given by vein 1 3 and 6 days after transplantation
Several medications are used for the prevention of infections potentially caused by fungal bacterial and viral organisms Some of these antibiotics are given by vein and some are given as pills for variable lengths of time You will receive medications while you are on tacrolimus or other medications that may weaken your immune system such as steroids in order to prevent infections such as pneumonia These antibiotics may include Bactrim Diflucan or other medications if necessary
You will be in the hospital for about 3-4 weeks after the transplant You will have check-ups every day until you leave the hospital After you leave the frequency of clinic visits will vary depending on your condition You may need to come to the hospital as often as daily
If your first bone marrow examination after transplantation determines that you are in remission you will be eligible to receive azacitidine in one of 3 doses Your dose and schedule of administration will be decided before you start the treatment Participants will be enrolled starting with the smallest dose and moving upwards in terms of dose if no side effects are detected Each participant will have an assigned dose This dose may be decreased or may be stopped or may not be given at all if certain side effects develop
Azacitidine will be given as an injection under the skin once a day over 5 days in a row This may be repeated once a month for up to 4 months after the transplant You will be assigned to receive the drug for one to four cycles You will have about 25 days of rest between each cycle of treatment a cycle is the period of 1 month If intolerable side effects occur treatment with azacitidine may be interrupted or stopped altogether before you finish treatment
While on study you will need to stay in Houston for up to 5 months after your transplant You will then be required to return at 9 and 12 months after the transplant though the frequency of the visits may be higher if thought necessary by your doctor After 1 year your follow-up will continue as is standard of care for your disease
This is an investigational study Azacitidine and the other drugs described here are approved by the FDA The use of azacitidine after allogeneic transplantation is experimentalAbout 90 patients will take part in this study All will be enrolled at M D Anderson
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in this study You will have a complete medical history and physical exam Women who are able to have children must have a negative blood pregnancy test
If you are found to be eligible to take part in this study you will be given chemotherapy before the transplant of donor cells There are 2 major goals to giving this chemotherapy One goal is to directly kill leukemic cells The other goal is to block your ability to reject the donor cells that will be given to your for the transplantation
All participants will receive a combination of 3 chemotherapy drugs--gemtuzumab fludarabine and melphalan In order to receive gemtuzumab your bone marrow leukemia cells have to be positive for a marker called CD33 which is present in the majority of myeloid leukemias If your cells are negative for that marker the chemotherapy you receive will not include gemtuzumab Anti-thymocyte globulin ATG will be given to patients receiving stem cells from an unrelated donor or from a relative that is not fully matched with you
All chemotherapy drugs are given by vein through a silicone catheter Gemtuzumab is given 12 days before the transplant may be given as an outpatient infusion Fludarabine is given once a day for 4 days 5-2 days before the transplant and melphalan is given as a single dose 2 days before the transplant If you are receiving ATG this drug will be given in 3 doses given 3-1days before the transplant The transplant day is usually referred to as Day 0
A total of 5 bone marrow biopsies will be collected during the first year after transplantation--before the start of treatment around 1 month after transplantation and around 4 9 and 12 months after transplantation To collect a bone marrow sample an area of the hip bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle The bone marrow samples will be used primarily for disease status evaluation but researchers will also use the samples for research on the way azacitidine works
Eleven 11 blood samples 2 teaspoons each will be collected for research purposes during the 1 year of your participation in this study Samples will be collected before chemotherapy before stem cell transplantation before and after you receive 5-azacitidine for each of the 4 cycles of treatment and on the third week of the first cycle of 5-azacitidine treatment
After the blood-forming cells are collected from the donor they will be given to you by vein for your transplant Before the infusion you will receive medications such as steroids and Benadryl diphenhydramine to decrease the risk of side effects These premedications are given by vein usually 30 to 60 minutes before the transplant
You will receive several medications to help the treatment work and to help decrease the risks of infections while your immune system is weak Tacrolimus and methotrexate will be given to decrease the risk of graft-versus-host disease GVHD a problem that may occur if the donors immune cells fight your body Tacrolimus will be started 2 days before the transplant and will continue for a variable period of time eg 3-12 months or longer if you develop GVHD Tacrolimus is given by vein at first and then by mouth when patients are able to eat Methotrexate is given by vein 1 3 and 6 days after transplantation
Several medications are used for the prevention of infections potentially caused by fungal bacterial and viral organisms Some of these antibiotics are given by vein and some are given as pills for variable lengths of time You will receive medications while you are on tacrolimus or other medications that may weaken your immune system such as steroids in order to prevent infections such as pneumonia These antibiotics may include Bactrim Diflucan or other medications if necessary
You will be in the hospital for about 3-4 weeks after the transplant You will have check-ups every day until you leave the hospital After you leave the frequency of clinic visits will vary depending on your condition You may need to come to the hospital as often as daily
If your first bone marrow examination after transplantation determines that you are in remission you will be eligible to receive azacitidine in one of 3 doses Your dose and schedule of administration will be decided before you start the treatment Participants will be enrolled starting with the smallest dose and moving upwards in terms of dose if no side effects are detected Each participant will have an assigned dose This dose may be decreased or may be stopped or may not be given at all if certain side effects develop
Azacitidine will be given as an injection under the skin once a day over 5 days in a row This may be repeated once a month for up to 4 months after the transplant You will be assigned to receive the drug for one to four cycles You will have about 25 days of rest between each cycle of treatment a cycle is the period of 1 month If intolerable side effects occur treatment with azacitidine may be interrupted or stopped altogether before you finish treatment
While on study you will need to stay in Houston for up to 5 months after your transplant You will then be required to return at 9 and 12 months after the transplant though the frequency of the visits may be higher if thought necessary by your doctor After 1 year your follow-up will continue as is standard of care for your disease
This is an investigational study Azacitidine and the other drugs described here are approved by the FDA The use of azacitidine after allogeneic transplantation is experimentalAbout 90 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