Study: NCT01875237

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: 40 mg/m2 by vein on Days -6 to -3.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Melphalan
Description: 140 mg/m2 by vein on Day -2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Alemtuzumab
Description: 50 mg by vein on Day -1.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Stem Cell infusion
Description: Stem cell infusion on Day 0. Goal is to administer more than 3 x 10\^6 CD34+ cells/kg of peripheral blood progenitor cells (PBPC).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tacrolimus
Description: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml (target is 10 ng/ml) between Day +1 and Day +45. Tacrolimus is changed to oral dosing when tolerated. Tacrolimus tapering should start on approximately Day +35 with the intention for the patient to be completely off the drug by approximately Day +45.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mini Methotrexate
Description: 5 mg/m2 by vein on Days +1, +3, +6.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: G-CSF
Description: 5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until the absolute neutrophil count (ANC) is \> 500 x 10/L for 3 consecutive days.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Donor Lymphocyte Infusion (DLI)
Description: iCasp9 (BPZ-1001)-Modified T-cells) of 3 X 10\^6/kg in 100 ml infused over approximately a one hour period between Day + 56 to Day +64.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AP1903
Description: 0.4 mg/kg as a 2 hour infusion for patients that present with a clinical diagnosis of grade I GvHD. For patients with a clinical diagnosis of grade \> 2 GvHD, a single dose of AP1903 0.4 mg/kg as a 2 hour infusion will be administered. Patients who fail to achieve a complete response within 72 hours of an initial dose of AP1903, or within 48 hours of a second dose of AP1903, will be maintained on this dose for no less than 7 days. Patients who experience a partial response within 72 hours may receive a second dose of AP1903. Patients whose GvHD is progressing after 7 days, have no response by 14 days, or are not in a complete response at day 28 can receive secondary therapy.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methylprednisolone
Description: 1.6 mg/kg per day by vein divided in 2 to 3 daily doses. Patients whose GvHD resolves as defined by a complete response within 72 hours, would have steroids stopped immediately. Patients who fail to achieve a complete response within 72 hours of an initial dose of AP1903, or within 48 hours of a second dose of AP1903, will be maintained on this dose for no less than 7 days. Steroids can then be tapered as tolerated to no less than 0.6 mg/kg per day at day 28.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Questionnaire
Description: Completion of a quality of life questionnaire that will take 10-15 minutes between Days + 28 and + 56, about twice a week until about 2 months after the T-cell infusion, and then 6 and 12 months after the stem cell transplant.