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
We expect that the patient's 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 1000/ul.
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Day 100 Non-relapse mortality,
Safety and feasibility of submyeloablative conditioning as a preparative regimen for blood stem cell transplantation
George Carrum, MD
Baylor College of Medicine
United States: Food and Drug Administration
|Texas Children's Hospital||Houston, Texas|
|The Methodist Hospital||Houston, Texas 77030|