Allogeneic Transplantation for Pediatric Leukemias With Unrelated Donors

Leukemia Clinical Trial

Official title: Allogeneic Transplantation for Pediatric Leukemias With Unrelated Donors Using Fludarabine, Busulfan, 400 cGy Total Body Irradiation, and Thymoglobulin

Status Recruiting

Clinical Trial Summary

The study proposes the use of Fludarabine, Busulfan, Anti Thymocyte Globulin Rabbit (ATG) and Total Body Irradiation as a preparative regimen before hematopoietic stem cell transplant from unrelated donor peripheral blood stem cells (PBSC). The hypothesis states that the 100 day mortality after this type of transplant will be significantly below the accepted standards, which is about 30% for unrelated donors.

Clinical Trial Description

The primary objective of this study is to evaluate the toxicity (as measured as 100 day survival) after hematopoietic stem cell transplant from an unrelated donor with a novel preparative regimen of Fludarabine, Busulfan, Anti-Thymocyte Globulin, and Total Body Irradiation for pediatric patients with leukemia. The secondary objectives are to evaluate the relapse-free and overall survival after hematopoietic stem cell transplant as well as to evaluate the incidence of acute and chronic graft-versus-host disease after this preparative regimen. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia

• NCT number: NCT00679536
• Study type: Interventional
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Sonali Chaudhury, MD
• Phone: 312-227-4863
• Email: schaudhury@luriechildrens.org
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 2008
• Completion date: May 2015