124
Participants
Start Date
March 7, 2016
Primary Completion Date
January 31, 2027
Study Completion Date
January 31, 2029
Cytarabine
Cytarabine 100 mg/m\^2/day IV for five consecutive days. This five-day cycle will be repeated every 21 days for a total of four cycles for all patients regardless of response. Each new cycle may not begin until absolute neutrophil count (ANC) is ≥ 750/mcL and platelet count is ≥ 75,000/mcL.
Vinblastine/prednisone
"Vinblastine/Prednisone +/- 6-mercaptopurine based on risk category. Patients with high-risk organ involvement (liver, spleen, hematopoeitic system) will receive 6-mercaptopurine during Continuation Therapy as this is the current standard of care treatment.~Vinblastine 6 mg/m\^2/dose IV push weekly for patients ≥ 12 months of age. Vinblastine will be dosed at 3 mg/m\^2/dose for patients under 6 months of age, and dosed at 4.5 mg/m\^2/dose for patients 6 months of age to 11.99 months of age.~Prednisone (or prednisolone) 20 mg/m2/dose by mouth twice a day"
RECRUITING
Lehigh Valley Health Network- Cedar Crest, Allentown
RECRUITING
Children's Hospital of The King's Daughters, Norfolk
RECRUITING
Nationwide Children's Hospital, Columbus
WITHDRAWN
University of Minnesota/Masonic Cancer Center, Minneapolis
RECRUITING
Cook Children's Health Care System, Fort Worth
RECRUITING
Texas Children's Hospital, Houston
RECRUITING
Children's Hospital of San Antonio, San Antonio
RECRUITING
Vannie Cook Children's Clinic, McAllen
RECRUITING
Dell Children's Medical Center, Austin
RECRUITING
Rady Children's Hospital - San Diego, San Diego
RECRUITING
Stanford Children's Hospital, Lucile Packard Children's Hospital, Palo Alto
Baylor College of Medicine
OTHER