Study: NCT05027945

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Allogeneic HSCT
Description: stem cell transplant on day 0

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Allogeneic HSCT
Description: stem cell transplant on day 0

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Busulfan test dose
Description: 0.8 mg/kg IV over 2 hours. May be skipped if real-time PKs are done during conditioning.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Busulfan test dose
Description: 0.8 mg/kg IV over 2 hours. May be skipped if real-time PKs are done during conditioning.

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

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

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tacrolimus
Description: Starting on day +5, start at 0.02 mg/kg IV continuous infusion over 24 hours until day +180 and titrated to trough levels of 5-15 mg/ml.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tacrolimus
Description: Starting on day +5, start at 0.02 mg/kg IV continuous infusion over 24 hours until day +180 and titrated to trough levels of 5-15 mg/ml.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Busulfan
Description: AUC Targeted Dose based on busulfan test dose PKs, IV infusion over 3 hours once daily (3.2 mg/kg IV per day will be the default dose) per the below time frame: For 8/8 Matched Related or Unrelated Donor Busulfan dose will be on days -6, -5, and -4 For 7/8 Matched Related or Unrelated or Haploidentical Donor Busulfan dose will be on days -4 and -3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Busulfan
Description: AUC Targeted Dose based on busulfan test dose PKs, IV infusion over 3 hours once daily (3.2 mg/kg IV per day will be the default dose) per the below time frame: For 8/8 Matched Related or Unrelated Donor Busulfan dose will be on days -6, -5, and -4 For 7/8 Matched Related or Unrelated or Haploidentical Donor Busulfan dose will be on days -4 and -3

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Total Body Irradiation (TBI)
Description: For 7/8 Matched Related or Unrelated or Haploidentical Donor, 200cGy on day -1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: 40 mg/m2 IV over 30 mins daily For 8/8 Matched Related or Unrelated Donor Fludarabine dose will be on days -6, -5, -4, and -3 For 7/8 Matched Related or Unrelated or Haploidentical Donor Fludarabine dose will be on days -6, -5, -4, -3, and -2

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: 40 mg/m2 IV over 30 mins daily For 8/8 Matched Related or Unrelated Donor Fludarabine dose will be on days -6, -5, -4, and -3 For 7/8 Matched Related or Unrelated or Haploidentical Donor Fludarabine dose will be on days -6, -5, -4, -3, and -2

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide (CY)
Description: For 7/8 Matched Related or Unrelated or Haploidentical Donor, prior to transplant 14.5 mg/kg IV daily on days -6 and -5

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Post-Transplant Cyclophosphamide (PTCY)
Description: Post-Transplant Cyclophosphamide: 50 mg/kg IV daily over 2 hours on days +3 and +4, dosed according to ideal body weight

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Post-Transplant Cyclophosphamide (PTCY)
Description: Post-Transplant Cyclophosphamide: 50 mg/kg IV daily over 2 hours on days +3 and +4, dosed according to ideal body weight