Low-Intensity Preparative Regimen and Allogeneic Peripheral Blood Stem Cell Transplantation From Unrelated Donor in Patients With Hematologic Malignancy
Combinations of high-dose chemotherapy and radiation therapy (preparative regimen) followed
with allogeneic bone marrow or stem cell transplantation from an unrelated donor is a
current treatment approach. Chemotherapeutic drugs and radiation are given in higher doses
to increase their effectiveness. High-dose chemotherapy and radiation therapy generally
affect cells that are dividing. They are used to treat cancer because cancer cells divide
more often than most other cells. High-dose treatment severely damages the patient's bone
marrow so that the patient no longer is able to produce needed blood cells. Peripheral stem
cell transplantation allows stem cells that were damaged by treatment to be replaced with
healthy stem cells that can produce the blood cells the patient needs. Patients experience a
number of complications after transplantation. Some are temporary and relatively minor; yet
others can be life threatening. Many doctors consider high-dose chemotherapy, by itself or
with radiation, and bone marrow or stem cell transplantation as the best available treatment
option for diseases under specific circumstances. However, this study will explore whether a
less-intensive preparative therapy before the peripheral stem cell transplantation will
prove to be safer, have less side effects, and be an effective treatment for certain
diseases.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- To evaluate the toxicity of low-intensity regimen for allogeneic stem cell transplantation from an unrelated donor.
John E. Levine, MS MD
Principal Investigator
The Univeristy of Michigan
United States: Institutional Review Board
UMCC 9970
NCT00146055
March 2000
October 2007
Name | Location |
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The University of Michigan | Ann Arbor, Michigan 48109 |