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Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT

Complete title: A Phase II Study of Treosulfan/Fludarabine/Low Dose Total Body Irradiation as a Preparative Regimen for Children with AML/MDS Undergoing Allogeneic Hematopoietic Cell Transplantation

Research Study Number       2701.00
Principal Investigator       Ann Dahlberg
Phase       II

Look up trial at NIH

Research Study Description

This is a prospective, open-label, nonrandomized, prospective clinical trial evaluating a fixed regimen of treosulfan, fludarabine and low-dose total body irradiation (TBI) in children with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT). The primary hypothesis is that HCT with a preparative regimen consisting of treosulfan, fludarabine and low-dose TBI will result in overall survival (OS) comparable to historical rates observed with conventional myeloablative regimens in the pediatric population. The preparative regimen will result in adequate incidence of neutrophil and platelet engraftment, and acceptable rates of graft-versus-host disease (GVHD), relapse and survival. The pharmacokinetic (PK) profile of treosulfan in children will be comparable to that of adults previously studied.

Eligibility Criteria (must meet the following to participate in this study)

- *For Eligibility information, please click on the "Look up trial at NIH" link above.

Other eligibility criteria may apply.

Research Study Number       2701.00
Contact       Connie Nakano, MPH
Telephone       206/667-3011

Acute Myeloid Leukemia (AML); Bone Marrow and Hematopoietic Stem Cell Transplant (BMT and HSCT); Hematologic Malignancies; Leukemia; Myelodysplastic and Myeloproliferative Syndromes (MDS and MPD)

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