Study: NCT01861106

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Allogeneic HSCT
Description: Stem cell transplant

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Allogeneic HSCT
Description: Stem cell transplant

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Allogeneic HSCT
Description: Stem cell transplant

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Allogeneic HSCT
Description: Stem cell transplant

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Busulfan Test dose
Description: 0.8 mg/kg IV infusion over 3 hours one time dose administered 5 to 14 days prior to start of preparative regimen (Days -11 to -20)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Busulfan Test dose
Description: 0.8 mg/kg IV infusion over 3 hours one time dose administered 5 to 14 days prior to start of preparative regimen (Days -11 to -20)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Busulfan Test dose
Description: 0.8 mg/kg IV infusion over 3 hours one time dose administered 5 to 14 days prior to start of preparative regimen (Days -11 to -20)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fludarabine (Fludara, Berlex Laboratories)
Description: 40 mg/m2 IV (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m2 IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fludarabine (Fludara, Berlex Laboratories)
Description: 40 mg/m2 IV (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m2 IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fludarabine (Fludara, Berlex Laboratories)
Description: 40 mg/m2 IV (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m2 IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fludarabine (Fludara, Berlex Laboratories)
Description: 40 mg/m2 IV (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m2 IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Busulfan (Busulfex)
Description: 3.2 mg/kg IV (in the vein) over 3 hours once daily on Days -6, -5, -4 and -3 (weight based dosing). If in Arm B and if poor or very poor risk clonal chromosomal abnormalities, busulfan will also be given on day -2.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Busulfan (Busulfex)
Description: 3.2 mg/kg IV (in the vein) over 3 hours once daily on Days -6, -5, -4 and -3 (weight based dosing). If in Arm B and if poor or very poor risk clonal chromosomal abnormalities, busulfan will also be given on day -2.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Busulfan (Busulfex)
Description: 3.2 mg/kg IV (in the vein) over 3 hours once daily on Days -6, -5, -4 and -3 (weight based dosing). If in Arm B and if poor or very poor risk clonal chromosomal abnormalities, busulfan will also be given on day -2.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cyclophosphamide (CTX, Cytoxan)
Description: 14.5 mg/kg IV (in the vein) infusion over 30 minutes once daily on days -6 and -5 (weight based dosing) or 50 mg/kg IV infusion over 2 hours on day -6 (weight based dosing). For post-transplant, 50/kg IV once daily x2 doses on days +3 and +4

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cyclophosphamide (CTX, Cytoxan)
Description: 14.5 mg/kg IV (in the vein) infusion over 30 minutes once daily on days -6 and -5 (weight based dosing) or 50 mg/kg IV infusion over 2 hours on day -6 (weight based dosing). For post-transplant, 50/kg IV once daily x2 doses on days +3 and +4

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cyclophosphamide (CTX, Cytoxan)
Description: 14.5 mg/kg IV (in the vein) infusion over 30 minutes once daily on days -6 and -5 (weight based dosing) or 50 mg/kg IV infusion over 2 hours on day -6 (weight based dosing). For post-transplant, 50/kg IV once daily x2 doses on days +3 and +4

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Total Body Irradiation (TBI)
Description: 200 cGy on Day -1

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Total Body Irradiation (TBI)
Description: 200 cGy on Day -1

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Mycophenolate mofetil (MMF)
Description: 15mg/kg IV over 2 hours BID starting on day +5 will continue until day +35 (+/- 2 days)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Mycophenolate mofetil (MMF)
Description: 15mg/kg IV over 2 hours BID starting on day +5 will continue until day +35 (+/- 2 days)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tacrolimus
Description: 0.02mg/kg IV continuous infusion over 24 hours starting on day +5 until day +180

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tacrolimus
Description: 0.02mg/kg IV continuous infusion over 24 hours starting on day +5 until day +180

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tacrolimus
Description: 0.02mg/kg IV continuous infusion over 24 hours starting on day +5 until day +180

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Equine Anti-Thymocyte Globulin
Description: (Deleted this intervention per amendment I): 30mg/kg IV (in the vein)once daily x 3 days on Days -6, -5, -4 (3 doses total)