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

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Acute Myeloid Leukemia (AML)Myelodysplastic Syndrome (MDS)
Interventions
DRUG

Treosulfan

This is a phase II, open-label, nonrandomized, prospective study of a preparative regimen consisting of treosulfan, fludarabine and low-dose total body irradiation (TBI) for children with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT).

Trial Locations (23)

20010

Children's National Medical Center, Washington D.C.

29425

Medical University of South Carolina, Charleston

33701

All Children's Hospital, St. Petersburg

35233

Children's Hospital of Alabama/UAB, Birmingham

38105

St. Jude's Children's Research Hospital, Memphis

43205

Nationwide Children's Hospital, Columbus

44106

University Hospitals Case Medical Center, Cleveland

44195

Cleveland Clinic, Cleveland

46202

Riley Hospital for Children/Indiana University, Indianapolis

48109

University of Michigan, Ann Arbor

53226

Medical College of Wisconsin/Children's Hospital of Wisconsin, Milwaukee

53705

University of Wisconsin - Madison, Madison

55455

University of Minnesota, Minneapolis

63130

Washington University, St. Louis Children's, St Louis

64108

Children's Mercy Hospital, Kansas City

78229

Methodist Children's Hospital of South Texas, San Antonio

80045

Children's Hospital of Colorado, Aurora

84111

Primary Children's Medical Center - University of Utah, Salt Lake City

85016

Phoenix Children's Hospital, Phoenix

91010

City of Hope, Duarte

97239

OHSU/Doernbecher Children's Hospital, Portland

98109

Fred Hutchinson Cancer Research Center, Seattle

99027

Children's Hospital Los Angeles, Los Angeles

All Listed Sponsors
collaborator

National Marrow Donor Program

OTHER

collaborator

Resource for Clinical Investigation in Blood and Marrow Transplantation (RCI BMT)

UNKNOWN

collaborator

Pediatric Blood and Marrow Transplant Consortium

OTHER

collaborator

St. Baldrick's Foundation

OTHER

collaborator

medac GmbH

INDUSTRY

lead

Center for International Blood and Marrow Transplant Research

NETWORK

NCT01772953 - Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT | Biotech Hunter | Biotech Hunter