Reduced Intensity Transplant Conditioning Regimen for Severe Thalassemia

PHASE2CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

April 30, 2014

Study Completion Date

July 31, 2014

Conditions
Severe Thalassemia
Interventions
DRUG

Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan

Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion

Trial Locations (18)

19104

The Children's Hospital of Philadelphia, Philadelphia

20010

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

27599

The University of North Carolina at Chapel Hill, Chapel Hill

27710

Duke University, Durham

30322

Emory University, Atlanta

33136

University of Miami, Miami

33701

All Children's Research Institute, Inc., St. Petersburg

37232

Vanderbilt University, Nashville

43205

The Research Institute at Nationwide Children's Hospital, Columbus

48109

University of Michigan, Ann Arbor

60614

Children's Memorial Hospital, Chicago

63110

Washington University, St Louis

75390

UT Southwestern Medical Center, Dallas

78229

Methodist Healthcare System of San Antonio, San Antonio

90095

Regents of University of California- UCLA, Los Angeles

94609

Children's Hospital and Research Center at Oakland, Oakland

97239

Oregon Health and Science University, Portland

02115

Dana Farber Cancer Institute, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Carelon Research

OTHER

collaborator

Pediatric Blood and Marrow Transplant Consortium

OTHER

lead

Washington University School of Medicine

OTHER