Spots Global Cancer Trial Database for Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT
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Trial Identification
Brief Title: Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT
Official 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
Study ID: NCT01772953
Interventions
Study Description
Brief Summary: 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.
Detailed Description: The proposed study will evaluate a regimen using treosulfan, fludarabine and low-dose TBI in children and adolescents with AML or MDS undergoing allogeneic HCT. We expect this regimen to yield lower toxicity and at least equivalent rates of disease control and overall survival, compared to current standard myeloablative regimens. The primary objective of this study is to determine the safety and preliminary efficacy of a transplant preparative regimen consisting of treosulfan, fludarabine and low-dose TBI for children with AML and MDS. The primary endpoint will be overall survival (OS) at one year. Secondary objectives to be studied include: pharmacokinetic (PK) profile of treosulfan in children \< 40 kg, non-relapse mortality, disease-free survival, incidences of neutrophil and platelet engraftment, donor chimerism, acute and chronic graft-versus-host disease (GVHD), and relapse.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital of Alabama/UAB, Birmingham, Alabama, United States
Phoenix Children's Hospital, Phoenix, Arizona, United States
City of Hope, Duarte, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Children's Hospital of Colorado, Aurora, Colorado, United States
Children's National Medical Center, Washington, DC, District of Columbia, United States
All Children's Hospital, St. Petersburg, Florida, United States
Riley Hospital for Children/Indiana University, Indianapolis, Indiana, United States
University of Michigan, Ann Arbor, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
Washington University, St. Louis Children's, St. Louis, Missouri, United States
University Hospitals Case Medical Center, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
OHSU/Doernbecher Children's Hospital, Portland, Oregon, United States
Medical University of South Carolina, Charleston, South Carolina, United States
St. Jude's Children's Research Hospital, Memphis, Tennessee, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, United States
Primary Children's Medical Center - University of Utah, Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
University of Wisconsin - Madison, Madison, Wisconsin, United States
Medical College of Wisconsin/Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Eneida Nemecek, MD
Affiliation: Doernbecher Children's Hospital, Oregon Health & Science University
Role: STUDY_CHAIR
Name: Colleen Delaney, MD
Affiliation: Seattle Children's Hospital, Fred Hutchinson Cancer Research Center
Role: STUDY_CHAIR
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