T-Regulatory Cell Kinetics for Patients Receiving Alemtuzamb and Undergoing Stem Cell Transplantation From HLA Mismatched-Related, or HLA Matched, or One Antigen Mismatched-Unrelated Donors
To participate in this transplant, the patient will need to have a central line.
Before the transplant we will test the blood for viruses which can cause problems after the
transplant. These viruses include Hepatitis B, cytomegalovirus and HIV. If the patient is
positive for the AIDS virus, they will not be able to undertake the transplant.
Standard therapy: The patient will be given 6 doses of chemotherapy with a drug called Ara C
in high doses (every 12 hours) which will begin 8 days before the stem cell transplant.
Then, another chemotherapy drug called cyclophosphamide will be given in high doses by vein
for two days on the 7th and 6th days before the transplant. A drug called MESNA will be
given with cyclophosphamide. MESNA is used to decrease the side effects caused by
cyclophosphamide. The patient will also receive an antibody called Campath (each day for 4
days before the transplant) to help destroy the immune system so that there is less host
resistance to the growth of the donor cells. Radiation treatment will be given to the entire
body on each day for 4 days before transplant. This will be given 2 times a day for 4 days.
The chemotherapy and radiation treatment will last 8 days. If the patient has a diagnosis of
T-cell Lymphoma, they will not be given the Ara-C.
Extra bone marrow tests may be recommended by the physician to check on the patients
condition, especially if the marrow is slow to grow.
The day after the radiation treatment is completed; the patient will receive the healthy
stem cells by vein. Once in the bloodstream, these stem cells will go to the bone marrow and
should begin to grow.
In prevention of GvHD, the patient will also receive medicine called FK506 as well as low
dose methotrexate. The FK506 will be given intravenously initially starting 2 days before
the transplant and later by mouth (when they are able to take oral medications). This drug
will be given each day for several weeks. Four doses of low dose methotrexate will be given
intravenously. The methotrexate will be given on the day after the transplant, 3, 6 and 11
days after the transplant. If the GVHD cannot be controlled with FK506, other medicines may
need to be given. The doctor will describe these medicines at that time.
Blood samples for research: To study how these cells are working in the patients system,
blood samples will be taken each month for six months, at nine months, at one year, 2 years
and 3 years following transplant. Approximately 6-8 teaspoons of blood will be collected
each time. The total blood drawn for this study over three years should not exceed 1 and 3/4
cups. This amount is considered safe in adults. The amount of blood collected will be
decreased in children and/or in patients where this amount of blood collection would not be
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To define the biologic recovery and behavior of T reg cells for pts undergoing stem cell transplant
Robert Krance, MD
Baylor College of Medicine
United States: Institutional Review Board
|Texas Children's Hospital||Houston, Texas|