43
Participants
Start Date
March 22, 2019
Primary Completion Date
November 30, 2026
Study Completion Date
November 30, 2026
Alemtuzumab
Alemtuzumab will be administered by either subcutaneous (SQ) injection or IV. A test dose of alemtuzumab, 3 mg, is administered on the first day. If the test dose is tolerated, administration of three treatment doses will begin within 24 hours. The three treatment doses will be administered on consecutive days. On the first day, 10 mg/m2 will be given, 15 mg/m\^2 the second and 20 mg/m\^2 the third. Alemtuzumab will be started between Days -22 and -20, but all doses (test dose and three treatment doses) should be completed by Day -18.
Fludarabine
Fludarabine will be administered at 30 mg/m\^2 IV daily for five days (Days -7 to -3).
Melphalan
Melphalan will be administered at 140 mg/m\^2 IV on Day -3 following fludarabine administration.
Children's Hospital of Philadelphia, Philadelphia
Children's National Hospital, Washington D.C.
University of North Carolina Medical Center, Chapel Hill
Atrium Health Levine Cancer Institute, Charlotte
Children's Healthcare of Altanta, Atlanta
Children's Hospital of Alabama, Birmingham
Riley Children's Health/Indiana University, Indianapolis
University of Chicago, Chicago
Washington University School of Medicine, St Louis
Phoenix Children's, Phoenix
Yale University, Yale Cancer Center, New Haven
Dana-Farber Cancer Institute/Boston Children's Hospital, Boston
Hackensack University Medical Center, Hackensack
Cancercare Manitoba/Winnipeg Children's Hospital, Winnipeg
Centre Hospitalier Universitaire Sainte-Justine, Montreal
Emory University
OTHER