drugset / Trial / NCT00679536

Allogeneic Transplantation for Pediatric Leukemias With Unrelated Donors

NCT00679536

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2008-05
Primary completion
2015-05
Completion
2015-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule
Subject Fludarabine Small molecule 30 mg/m2
Subject Thymoglobulin Protein / enzyme biologic 1.5 mg/kg

Indications