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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hematologic Neoplasms, Graft-Versus-Host Disease

Intervention / Treatment
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* Device: Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Alpha-beta depleted T-cell infusion<br>Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide. | Device: Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.<br>* Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD) | Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria. | From baseline and before day +100 of transplant. | 
| Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD) | Patients will be monitored for Grade IV cGVHD and organ toxicity. Chronic assessment will be done using the conventional criteria. | From baseline and before day +100 of transplant. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stem cell transplant