Low-Intensity Preparation and Allogeneic Transplant in Patients With Cancers of the Blood
The purpose of this study is to determine whether a less-intensive preparative therapy followed by an allogeneic peripheral stem cell transplantation will provide an effective treatment for your disease and whether it will be associated with fewer side effects.
Procedure: Reduced intensity conditioning with allogeneic transplant
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Low-Intensity Preparative Regimen and Allogeneic Peripheral Blood Stem Cell Transplantation From Unrelated Donor in Patients With Hematologic Malignancy|
- - To evaluate the toxicity of low-intensity regimen for allogeneic stem cell transplantation from an unrelated donor.
- - To evaluate the engraftment, and chimerism.
- - To estimate the rate of acute GVHD, relapse and survival.
|Study Start Date:||March 2000|
|Study Completion Date:||October 2007|
|Primary Completion Date:||November 2004 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00146055
|United States, Michigan|
|The University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||John E. Levine, MS MD||The Univeristy of Michigan|