Study: NCT02356159

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Conditioning chemotherapy
Description: Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3; Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3 Furosemide: 20 mg IV flat dose on days -6, -5, -4, -3; Furosemide: 20 mg IV flat dose on days -6, -5, -4, -3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TMS
Description: Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +60 if no acute GVHD then at day +100 and discontinue at day +180 as tolerated. Methotrexate: 5 mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 60, followed by a taper if GVHD does not develop.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TMS
Description: Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +60 if no acute GVHD then at day +100 and discontinue at day +180 as tolerated. Methotrexate: 5 mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 60, followed by a taper if GVHD does not develop.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FLAG
Description: Fludarabine: 25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FLAG
Description: Fludarabine: 25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: EPOCH-F
Description: Fludarabine: 25 mg/m2 per day IV infusion over 30 minutes, daily on days 1-4. Etoposide: 50 mg/m2 per day continuous IV infusion over 24 hours on days 1-4. Doxorubicin: 10 mg/m2/day CIV, days 1-4. Vincristine: 0.4 mg/m2 per day continuous IV infusion over 24 hours daily on days 1-4 Cyclophosphamide: 750 mg/m2 IV infusion over 30 minutes on day 5 Prednisone: 60 mg/m2 per day PO daily on days 1-5. Filgrastim: 5 mcg/kg per day SC or IV.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: EPOCH-F
Description: Fludarabine: 25 mg/m2 per day IV infusion over 30 minutes, daily on days 1-4. Etoposide: 50 mg/m2 per day continuous IV infusion over 24 hours on days 1-4. Doxorubicin: 10 mg/m2/day CIV, days 1-4. Vincristine: 0.4 mg/m2 per day continuous IV infusion over 24 hours daily on days 1-4 Cyclophosphamide: 750 mg/m2 IV infusion over 30 minutes on day 5 Prednisone: 60 mg/m2 per day PO daily on days 1-5. Filgrastim: 5 mcg/kg per day SC or IV.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Hematopoietic stem cell transplant
Description: Hematopoietic stem cell transplant

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Hematopoietic stem cell transplant
Description: Hematopoietic stem cell transplant

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palifermin
Description: Escalating doses of palifermin given during transplant phase

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Palifermin
Description: Escalating doses of palifermin given during transplant phase