Clinical trial NCT02193880: Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)
Official title: Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Neoplasms
Graft-Versus-Host Disease
Keywords: stem cell transplant
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2014-07-18
Enrollment: 7
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD)
timeFrame: From baseline and before day +100 of transplant.
measure: Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD)
timeFrame: From baseline and before day +100 of transplant.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Medical Center (University of Alabama at Birmingham)
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ayman Saad, MD
role: PRINCIPAL_INVESTIGATOR
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