Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475020
Status:
COMPLETED
Last Update Posted:
2019-05-21
First Post:
2007-05-15
Brief Title:
Allogeneic Stem Cell Transplantation for Myelofibrosis and Myelodysplastic Syndrome
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Allogeneic Stem Cell Transplantation for Myelofibrosis and Myelodysplastic Syndrome Using Reduced Intensity Busulfan and Fludarabine Conditioning
Status:
COMPLETED
Status Verified Date:
2019-05
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 learn if using a combination of fludarabine busulfan and antithymocyte globulin ATG can help to control myelofibrosis or myelodysplastic syndrome in patients receiving a bone marrow or blood stem cell transplant The safety of these drugs will also be studied
Detailed Description:
Busulfan is a chemotherapy drug that kills cancer cells by binding to DNA and is commonly used in stem cell transplants Fludarabine is a drug that has anti-leukemia and immunosuppressive effects ATG helps to reduce the risk of transplant rejection and to prevent graft versus host disease
You will receive fludarabine by vein over 1 hour on Days -5 to -2 You will receive busulfan by vein over 3 hours on Day -5 to -2 immediately after completing fludarabine If you have an unrelated or a mismatched donor you will receive ATG by vein over 6 hours on Days -3 to -1 to prevent graft versus host disease and to help engraftment
You will first receive a low-level test dose of busulfan and blood samples about 1 teaspoon each time will be drawn for pharmacokinetic PK tests This may be done as an outpatient prior to inpatient admission PK tests measure the level of the study drug in the blood over different time points This information will be used to decide the next dose needed to reach the target blood level that matches your body size
About 11 total samples of blood will be drawn for PK testing after the test dose and before the first high-dose busulfan treatment A heparin lock will be placed in your 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 or for any other reason you will receive the standard fixed busulfan dose without the test dose
You will receive the donor bone marrow or blood stem cells by vein over about 1 hour on Day 0
Two 2 days before the stem cell infusion on Day -2 tacrolimus will be started as a non-stop infusion by vein and will be changed to oral tablets before you leave the hospital You will continue to take tacrolimus by mouth for at least 4 months
Four 4 doses of Methotrexate will be give as a short infusion Day 1 Day 3 Day 6 and Day 11 after stem cell infusion Both these are given to decrease the risk of getting graft-vs-host disease GvHD Further immunosuppressive therapy with methylprednisolone a steroid or other drugs may also be used to treat GvHD if it occurs
You will have 3 teaspoonfuls of blood drawn for routine tests every day while you are in the hospital and at least 2 times a week for the first 100 days after transplant You may need frequent blood transfusions and may have to be admitted to the hospital to receive antibiotics if you get a fever Three 3 teaspoonful of blood and a bone marrow aspirate and biopsy will be taken 1 month 3 months 6 months 12 months 18 months and 24 months after the transplant to check the response to the treatment After the first 2 years your disease status will be followed by a yearly phone call or letter from you or your regular doctor to the study doctor
Tests andor procedures may be performed before the scheduled time if your doctor thinks it is needed
You will be taken off the study if your disease gets worse or if further treatment is not in your best interest
This is an investigational study All the drugs to be used in this study are FDA approved and commercially available About 110 patients will take part in this study All will be enrolled at MD Anderson
You will receive fludarabine by vein over 1 hour on Days -5 to -2 You will receive busulfan by vein over 3 hours on Day -5 to -2 immediately after completing fludarabine If you have an unrelated or a mismatched donor you will receive ATG by vein over 6 hours on Days -3 to -1 to prevent graft versus host disease and to help engraftment
You will first receive a low-level test dose of busulfan and blood samples about 1 teaspoon each time will be drawn for pharmacokinetic PK tests This may be done as an outpatient prior to inpatient admission PK tests measure the level of the study drug in the blood over different time points This information will be used to decide the next dose needed to reach the target blood level that matches your body size
About 11 total samples of blood will be drawn for PK testing after the test dose and before the first high-dose busulfan treatment A heparin lock will be placed in your 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 or for any other reason you will receive the standard fixed busulfan dose without the test dose
You will receive the donor bone marrow or blood stem cells by vein over about 1 hour on Day 0
Two 2 days before the stem cell infusion on Day -2 tacrolimus will be started as a non-stop infusion by vein and will be changed to oral tablets before you leave the hospital You will continue to take tacrolimus by mouth for at least 4 months
Four 4 doses of Methotrexate will be give as a short infusion Day 1 Day 3 Day 6 and Day 11 after stem cell infusion Both these are given to decrease the risk of getting graft-vs-host disease GvHD Further immunosuppressive therapy with methylprednisolone a steroid or other drugs may also be used to treat GvHD if it occurs
You will have 3 teaspoonfuls of blood drawn for routine tests every day while you are in the hospital and at least 2 times a week for the first 100 days after transplant You may need frequent blood transfusions and may have to be admitted to the hospital to receive antibiotics if you get a fever Three 3 teaspoonful of blood and a bone marrow aspirate and biopsy will be taken 1 month 3 months 6 months 12 months 18 months and 24 months after the transplant to check the response to the treatment After the first 2 years your disease status will be followed by a yearly phone call or letter from you or your regular doctor to the study doctor
Tests andor procedures may be performed before the scheduled time if your doctor thinks it is needed
You will be taken off the study if your disease gets worse or if further treatment is not in your best interest
This is an investigational study All the drugs to be used in this study are FDA approved and commercially available About 110 patients will take part in this study All will be enrolled at MD Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01477 | REGISTRY | NCI CTRP | None |