Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Diseases Using Haploidentical Family Donors and Sub-Myeloablative Conditioning With Campath 1H
Before treatment begins, stem cells will be collected from the donor's blood or bone marrow.
The stem cells will be collected and frozen before we start to give the patient
After admission to the hospital, patients will receive total body irradiation (very strong
type of x-rays that kill cells in the bone marrow), Fludarabine and Campath 1H prior to the
Stem cell transplant (infusion of the donors stem cells).
Starting 7 days after the transplant, the patient will be given G-CSF by subcutaneous
injection until a blood test shows that granulocytes (a type of white blood cell) are more
than 1000/ul. This is to help increase blood counts.
After transplantation, the patient will have several evaluations at different times. These
are standard evaluations and tests done for any patient who has received a stem cell
transplant as part of routine clinical monitoring:
We will also be looking at the patient's immune function (how the body protects itself to
prevent and fight infections and diseases). To do this blood tests will be done at regular
intervals (every 3 to 6 months) for 2 years.
Depending on how well the donors stem cells work in the body after the transplant, the
patient may receive one or more Donor Leukocyte Infusions (DLI). This is when leukocytes (a
type of white blood cell) collected from the same donor that provided the stem cells are
given to the patient through a central line into a vein.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess the treatment related mortality
George Carrum, MD
Baylor College of Medicine; The Methodist Hospital
United States: Food and Drug Administration
|Texas Children's Hospital||Houston, Texas|
|The Methodist Hospital||Houston, Texas 77030|