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

Ayman Saad

Status: Completed

Conditions: Hematologic Neoplasms; Graft-Versus-Host Disease

Treatments: Device: Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

Study type: Interventional

Funder types: Other

Identifiers

NCT02193880

UAB 1397

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 7 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Alpha-beta depleted T-cell infusion

Other group

Description:

Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

Treatment:

Device: Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.