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

Hematologic Neoplasms Clinical Trial

— ABD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02193880
• Other study ID #: UAB 1397
• Status: Completed
• Phase: N/A
• Start date: October 9, 2014
• Est. completion date: March 13, 2018

Study information

• Verified date: April 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: March 13, 2018
• Est. primary completion date: March 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-Versus-Host Disease
• Hematologic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	UAB Medical Center (University of Alabama at Birmingham)	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Ayman Saad

Country where clinical trial is conducted

United States, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.

External Links

•   Click here for more information about the Bone Marrow Transplantation and Cell Therapy Program at the University of Alabama at Birmingham.