Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)

Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)

The purpose of this study is to determine the safety and efficacy of post-transplant cyclophosphamide and a post-transplant infusion of donor cells, that have been specially processed to remove alpha beta t-cells, in patients undergoing a haploidentical allogeneic stem cell transplant to help reduce the risk of relapse without increasing the risk of graft-versus-host disease.

Transplant patients participating in this clinical trial will receive one of 3 standard pre-transplant chemotherapy preparative regimens as appropriate for their specific disease. They will then receive a standard non-manipulated donor stem cell infusion on transplant day (day 0) followed by cyclophosphamide (days +3 and +4) and an alpha-beta t-cell reduced donor stem cell infusion on day +7.

Inclusion Criteria:

• Neoplastic hematological disorder with indication of allogeneic transplant
• No available suitable HLA-matched donor
• Adequate cardiac, pulmonary, renal, and hepatic function
• Karnofsky performance status score greater than or equal to 70%

Exclusion Criteria:

• Medication non-compliance
• No appropriate caregiver identified
• Uncontrolled medical or psychiatric disorder
• Active central nervous system (CNS) neoplastic involvement
• Known allergy to Dimethyl Sulfoxide
• HIV1 or HIV2 positive
• Pregnant or breastfeeding