NCT02193880

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Ayman Saad · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Hematologic Neoplasms
• Graft-Versus-Host Disease

Interventions

Type	Name	Description
DEVICE	Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.	Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.

Timeline

• Start date: 2014-10-09
• Primary completion: 2018-03-13
• Completion: 2018-03-13
• First posted: 2014-07-18
• Last updated: 2019-04-25
• Results posted: 2019-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study