Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069992
Status:
TERMINATED
Last Update Posted:
2012-10-10
First Post:
2003-10-03
Brief Title:
Total-Body Irradiation Fludarabine and Alemtuzumab Followed By Stem Cell Transplant in Treating Patients With Myeloproliferative Disorder MS AML or CML
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Safety And Efficacy of Sub-Myeloablative Allogeneic Stem Cell Transplantation For Patients With Myeloproliferative Disorder MPD Myelodysplastic Syndrome MDS Acute Myelogenous Leukemia AML or Chronic Myelogenous Leukemia
Status:
TERMINATED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed due to competing protocols
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MPDMDSBMT
Brief Summary:
Patients are being asked to participate in this study because they have a malignant blood disease such as Myelodysplastic Syndrome MDS Myeloproliferative Disorder MPD Acute Myelogenous Leukemia AML or Chronic Myelogenous Leukemia CML We feel that patients could benefit from an allogeneic meaning the cells come from a donor other than themself stem cell transplant The donor would be a family member or an unrelated person that is felt to be a good match for the patient Stem cells are cells that are made in the bone marrow spongy material that fills the middle of the bones As the stem cells grow they change into different types of blood cells that they need This includes red blood cells that carry oxygen around the body white blood cells that help to fight infections and platelets that help to prevent and stop bleeding Usually patients are given high doses of chemotherapy before a stem cell transplant High doses of chemo destroy the bone marrow Healthy stem cells from a donor are then given to replace the patients unhealthy cells However because of complications with the patients disease they have a high risk of having life-threatening side effects These include serious damage to organs such as the lung liver kidney and heart There is also an increased risk of bacterial fungal and viral infections The other major problem is when a donors stem cells also called the graft find that the patients cells the host cells are not the same The donor cells may try to destroy the hosts cells The cells at high risk are those of the skin liver and intestines This is called graft versus host disease GVHD and it can be fatal
Recently doctors have been able to use less toxic chemotherapy treatments before patients receive their transplants This less toxic treatment helps reduce some of the treatment related problems mentioned above Patients are being asked to be involved in a research study that uses this approach One major risk of this low dose treatment is that the patients body may reject the donor cells This is called graft rejection This study is designed to see if this low dose treatment is safe and effective
This treatment plan adds CAMPATH 1H a special protein called an antibody to a low dose chemotherapy regimen After chemo the patient will receive an allogeneic cells come from a donor stem cell transplant Adding CAMPATH 1H to the transplant medicines may help in treating the disease CAMPATH 1H may reduce life-threatening and treatment related side effects like GVHD CAMPATH 1H stays active in the body for a long time which means it may work longer to prevent GVHD CAMPATH 1H destroys lymphocytes a type of white cells that help fight infection and this helps prevent graft rejection
We want to see if the addition of CAMPATH 1H to the patients pre-transplant low dose chemotherapy will decrease the side effects from an allogeneic stem cell transplant while providing a curative treatment for patients with blood disorders
Recently doctors have been able to use less toxic chemotherapy treatments before patients receive their transplants This less toxic treatment helps reduce some of the treatment related problems mentioned above Patients are being asked to be involved in a research study that uses this approach One major risk of this low dose treatment is that the patients body may reject the donor cells This is called graft rejection This study is designed to see if this low dose treatment is safe and effective
This treatment plan adds CAMPATH 1H a special protein called an antibody to a low dose chemotherapy regimen After chemo the patient will receive an allogeneic cells come from a donor stem cell transplant Adding CAMPATH 1H to the transplant medicines may help in treating the disease CAMPATH 1H may reduce life-threatening and treatment related side effects like GVHD CAMPATH 1H stays active in the body for a long time which means it may work longer to prevent GVHD CAMPATH 1H destroys lymphocytes a type of white cells that help fight infection and this helps prevent graft rejection
We want to see if the addition of CAMPATH 1H to the patients pre-transplant low dose chemotherapy will decrease the side effects from an allogeneic stem cell transplant while providing a curative treatment for patients with blood disorders
Detailed Description:
We expect that the patients participation in this study will last approximately 18 months to 2 years
Before treatment begins they will be evaluated to confirm they meet the requirements of this study The evaluation includes HIV testing HIV Human Immunodeficiency Virus is the virus that causes Acquired Immune Deficiency Syndrome AIDS If the patient is HIV positive they will not be able to be treated on this protocol
The patient will need to have a central line This is a thin plastic catheter or tube that is placed during surgery into one of the large veins in the chest or neck Central lines are used to give medications IV intravenous by vein or to take blood samples without having to endure frequent needle sticks
After admission to the hospital the subject will receive
Day -6 a single dose of total body irradiation
Day -5 to Day -2 Chemotherapy Fludarabine plus Campath 1H through a catheter inserted into a vein IV
Day -2 FK506 given IV over a 24 hour period until the patient can take medication by mouth When they can take oral medication they will take this medication by mouth every 12 hours
Day -1 a day of rest
Day 0 the stem cell transplant infusion will be given
Day 7 G-CSF will be given by subcutaneous injection until your white blood cells granulocytes are greater than 1000ul
After transplantation they will be evaluated as follows Routine history physical examination blood tests and radiology studies will be done as needed for clinical care Bone marrow aspirate and biopsy will be done on or about day 30 60 and 100 180 and then yearly and as needed
Before treatment begins they will be evaluated to confirm they meet the requirements of this study The evaluation includes HIV testing HIV Human Immunodeficiency Virus is the virus that causes Acquired Immune Deficiency Syndrome AIDS If the patient is HIV positive they will not be able to be treated on this protocol
The patient will need to have a central line This is a thin plastic catheter or tube that is placed during surgery into one of the large veins in the chest or neck Central lines are used to give medications IV intravenous by vein or to take blood samples without having to endure frequent needle sticks
After admission to the hospital the subject will receive
Day -6 a single dose of total body irradiation
Day -5 to Day -2 Chemotherapy Fludarabine plus Campath 1H through a catheter inserted into a vein IV
Day -2 FK506 given IV over a 24 hour period until the patient can take medication by mouth When they can take oral medication they will take this medication by mouth every 12 hours
Day -1 a day of rest
Day 0 the stem cell transplant infusion will be given
Day 7 G-CSF will be given by subcutaneous injection until your white blood cells granulocytes are greater than 1000ul
After transplantation they will be evaluated as follows Routine history physical examination blood tests and radiology studies will be done as needed for clinical care Bone marrow aspirate and biopsy will be done on or about day 30 60 and 100 180 and then yearly and as needed
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