HLA-Mismatched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematological Malignancies
Many patients with hematological malignancies potentially curable by bone marrow
transplantation are not considered for transplantation because an HLA identical family or
unrelated donor is unavailable. For these patients the only curative option is a transplant
from a partially matched family donor. Such transplants are feasible but are less
successful than matched sibling donor transplants. The main problems with mismatched
transplants are graft rejection, graft-vs-host disease, and regimen-related mortality. This
restricts the use of mismatched transplants to patients less than 45 years at high risk of
dying from the hematological malignancy.
This protocol evaluates a new preparative regimen designed to ensure stem cell engraftment
by increased immunosuppression, followed by a G-CSF mobilized T cell depleted, stem cell
rich, peripheral blood progenitor cell (PBPC) transplant from a mismatched related donor in
patients with high risk hematological malignancies.
This phase I study evaluates engraftment and GVHD following T cell depleted, HLA-mismatched
PBPC transplants. Stopping rules will be used to make modifications to the protocol in the
event of graft failure.
The end points of the study are graft take, acute and chronic GVHD, leukemic relapse,
transplant-related mortality, death and leukemia-free survival. Patients will be followed
up for 5 years. It is planned to treat up to 35 patients aged between 10 and 45 years.
Endpoint Classification: Safety Study, Primary Purpose: Treatment
United States: Federal Government
|National Heart, Lung and Blood Institute (NHLBI)||Bethesda, Maryland 20892|