NCT02193880: ABD

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

Completed NA Results posted Last updated 25 April 2019

What this trial tests

NA trial testing Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide. in Hematologic Neoplasms in 7 participants. Completed in 13 March 2018.

Timeline

9 October 2014

Primary endpoint
13 March 2018

13 March 2018

Quick facts

Lead sponsor	Ayman Saad
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	9 October 2014
Primary completion	13 March 2018
Estimated completion	13 March 2018
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Hematologic Neoplasms — all drugs for Hematologic Neoplasms →
• Graft-Versus-Host Disease — all drugs for Graft-Versus-Host Disease →

Sponsor

Ayman Saad

Who can join

Adults 19 to 65, any sex, with Hematologic Neoplasms or Graft-Versus-Host Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD) Primary · From baseline and before day +100 of transplant.

Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria.

Group	Value	95% CI
Alpha-beta Depleted T-cell Infusion	0

Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD) Primary · From baseline and before day +100 of transplant.

Patients will be monitored for Grade IV cGVHD and organ toxicity. Chronic assessment will be done using the conventional criteria.

Group	Value	95% CI
Alpha-beta Depleted T-cell Infusion	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline through one year.. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Alpha-beta Depleted T-cell Infusion

Serious: 2/4 (50%)

Deaths: 3/4

Serious adverse events (1 terms)

Reaction	System	Alpha-beta Depleted T-cell…
Graft Failure (not related to study)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—

Other adverse events (1 terms — click to expand)

Reaction	System	Alpha-beta Depleted T-cell…
Infection	Infections and infestations	—

Most-reported serious reactions: Graft Failure (not related to study).

Data from ClinicalTrials.gov NCT02193880 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ex vivo T-cell depletion in allogeneic hematopoietic stem cell transplant: past, present and future.
   Saad A, Lamb LS. · · 2017 · cited 45× · PMID 28319073 · DOI 10.1038/bmt.2017.22
2. Role of αβ T Cell Depletion in Prevention of Graft versus Host Disease.
   Abdelhakim H, Abdel-Azim H, Saad A. · · 2017 · cited 28× · PMID 28672883 · DOI 10.3390/biomedicines5030035