Study: NCT01220297

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sirolimus
Description: Immunosuppressant administered orally to:~* Adults (age 14 and older), beginning on Day -3 with 12 mg loading dose, followed by 4 mg/day.~* Children \< 13 years or weighing 40 kg, beginning on Day -3 with 3 mg/m² loading dose, followed by 1 mg/ m², rounded to the nearest full milligram.~Daily dosage may be adjusted to maintain a target serum trough level of 3 to 12 ng/ml. Sirolimus dose tapering will begin at Day 100 in the absence of GvHD, with the goal of discontinuation by 6 months.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sirolimus
Description: Immunosuppressant administered orally to:~* Adults (age 14 and older), beginning on Day -3 with 12 mg loading dose, followed by 4 mg/day.~* Children \< 13 years or weighing 40 kg, beginning on Day -3 with 3 mg/m² loading dose, followed by 1 mg/ m², rounded to the nearest full milligram.~Daily dosage may be adjusted to maintain a target serum trough level of 3 to 12 ng/ml. Sirolimus dose tapering will begin at Day 100 in the absence of GvHD, with the goal of discontinuation by 6 months.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mycophenolate mofetil (MMF)
Description: Immunosuppressant given intravenously (IV) at 15 mg/kg 3 times daily, starting on Day 0 ≥ 2 hr after the completion of the HSCT infusion. Dose of MMF will be based on actual body weight, but limited to 15 kg above ideal body weight. MMF dose tapering will begin at Day 100 in the absence of GvHD, with the goal of discontinuation by 6 months.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mycophenolate mofetil (MMF)
Description: Immunosuppressant given intravenously (IV) at 15 mg/kg 3 times daily, starting on Day 0 ≥ 2 hr after the completion of the HSCT infusion. Dose of MMF will be based on actual body weight, but limited to 15 kg above ideal body weight. MMF dose tapering will begin at Day 100 in the absence of GvHD, with the goal of discontinuation by 6 months.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carmustine
Description: For Carmustine + Etoposide + Cyclophosphamide cohort, chemotherapy administered IV on Day -6 at the lesser of 15 mg/kg or 550 mg/m².

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etoposide
Description: For Carmustine + Etoposide + Cyclophosphamide cohort, chemotherapy administered IV on Day -4 at 60 mg/kg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide (Cyclo, CY)
Description: Cyclophosphamide is a chemotherapy agent.~For FTBI + Cyclophosphamide cohort, administered IV on Day -3 and -2 at 60 mg/kg.~For Carmustine + Etoposide + Cyclophosphamide cohort, administered IV on Day -2 at 100 mg/kg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide (Cyclo, CY)
Description: Cyclophosphamide is a chemotherapy agent.~For FTBI + Cyclophosphamide cohort, administered IV on Day -3 and -2 at 60 mg/kg.~For Carmustine + Etoposide + Cyclophosphamide cohort, administered IV on Day -2 at 100 mg/kg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FTBI
Description: For FTBI + Cyclophosphamide cohort, administered as 1320 cGy delivered in 11 120 cGy fractions over 4 days starting on Day -7.