Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

November 30, 2005

Primary Completion Date

June 30, 2024

Study Completion Date

March 11, 2025

Conditions
LeukemiaMyelodysplastic SyndromesChildhood Acute Myeloid Leukemia in RemissionRecurrent Childhood Acute Myeloid LeukemiaSecondary Acute Myeloid LeukemiaChildhood Acute Lymphoblastic Leukemia in RemissionPreviously Treated Myelodysplastic SyndromeSecondary Myelodysplastic SyndromeRefractory Anemia With Excess Blasts in TransformationRefractory Anemia With Excess BlastsRefractory AnemiaDe Novo Myelodysplastic SyndromeChildhood Myelodysplastic Syndrome
Interventions
BIOLOGICAL

filgrastim

All patients will receive G-CSF 5 mcg/kg/day intravenous (IV) (dose rounded to vial size) based on the actual body weight IV beginning on day +1 after umbilical cord blood (UCB) infusion. G-CSF will be administered daily until the absolute neutrophil count (ANC) exceeds 2.5 x 10\^9/L for three consecutive days and then discontinued. If the ANC decreases to \<1.0 x 10\^9/L, G-CSF will be reinstituted.

DRUG

busulfan

Administered 1.1 mg/kg if \<12 kg intravenous (IV) every 6 hours (0.8 mg/kg if \>12 kg IV every 6 hours on Days -8 through -5.

DRUG

cyclosporine

Patients will receive cyclosporine (CSA) therapy beginning on day -3 maintaining a level of \>200 ng/mL. For children \< 40 kg the initial dose will be 2.5 mg/kg intravenous (IV) over 2 hours every 8 hours.

DRUG

fludarabine phosphate

Administered 25 mg/m\^2 intravenous (IV) over 60 minutes on Days -4 through -2.

DRUG

melphalan

Administered 60 mg/m\^2 intravenous (IV) over 30 minutes on Days -4 through -2.

DRUG

mycophenolate mofetil

All patients will begin mycophenolate mofetil (MMF) on day -3. Patients \<45 kilograms will receive MMF at the dose of 15 mg/kg/dose every 8 hours (max dose 1gm/dose) orally or intravenously (PO or IV).

PROCEDURE

umbilical cord blood transplantation

The product is infused via IV drip directly into the central line without a needle, pump or filter on Day 0.

Trial Locations (1)

55455

Masonic Cancer Center, University of Minnesota, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT00357565 - Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia | Biotech Hunter | Biotech Hunter