Study: NCT01041508

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Clofarabine
Description: Clofarabine will be given as an intravenous infusion over 2 hours on days -6 though -2. The dose of Clofarabine will be assigned at study entry (30, 40 or 52 mg/m2).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Clofarabine
Description: Clofarabine will be given as an intravenous infusion over 2 hours on days -6 though -2. The dose of Clofarabine will be assigned at study entry (30, 40 or 52 mg/m2).

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Total Body Irradiation
Description: Low dose (2 Gy) TBI will be administered from a linear accelerator at ≤ 20 cGy/min on day 0 according to institutional guidelines.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Total Body Irradiation
Description: Low dose (2 Gy) TBI will be administered from a linear accelerator at ≤ 20 cGy/min on day 0 according to institutional guidelines.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Stem Cell Transplantation
Description: Patients will be infused with 'unmanipulated' hematopoietic stem cells from a related or unrelated donor on day 0 of the treatment regimen according to institutional practice guidelines.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Stem Cell Transplantation
Description: Patients will be infused with 'unmanipulated' hematopoietic stem cells from a related or unrelated donor on day 0 of the treatment regimen according to institutional practice guidelines.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclosporine
Description: Cyclosporine is given IV based on body weight at:~* Age ≤ 6 years old: 6 mg/kg IV QD. in divided doses (e.g. 2 mg/kg q8hrs).~* Age \> 6 years old: 3 mg/kg IV QD in divided doses (1.5mg/kg q12hrs)~Cyclosporine should be started on day -1 after completion of Clofarabine. Levels should be maintained between 300-400 ng/ml.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclosporine
Description: Cyclosporine is given IV based on body weight at:~* Age ≤ 6 years old: 6 mg/kg IV QD. in divided doses (e.g. 2 mg/kg q8hrs).~* Age \> 6 years old: 3 mg/kg IV QD in divided doses (1.5mg/kg q12hrs)~Cyclosporine should be started on day -1 after completion of Clofarabine. Levels should be maintained between 300-400 ng/ml.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mycophenolate Mofetil
Description: MMF will be at 15 mg/kg, based on adjusted body weight, q 8 hours (45 mg/kg/day; max.3g/day) PO, or IV if indicated, from the evening of day 0 (i.e. first dose 4-6 hours following stem cell infusion) to day +40 post-transplant. Oral doses will be rounded to the nearest 250 mg (capsules are 250 mg). MMF is also available in oral suspension form. MMF will be given until day +40 post transplant and then tapered by 10% per week to be discontinued by day +90.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mycophenolate Mofetil
Description: MMF will be at 15 mg/kg, based on adjusted body weight, q 8 hours (45 mg/kg/day; max.3g/day) PO, or IV if indicated, from the evening of day 0 (i.e. first dose 4-6 hours following stem cell infusion) to day +40 post-transplant. Oral doses will be rounded to the nearest 250 mg (capsules are 250 mg). MMF is also available in oral suspension form. MMF will be given until day +40 post transplant and then tapered by 10% per week to be discontinued by day +90.