CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
ATIRbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01794299
NCT01794299Phase 2Completed
CompareCT.gov

An Exploratory, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of ATIR, Donor T-lymphocytes Depleted ex Vivo of Host Alloreactive T-cells, in Patients With a Hematologic Malignancy, Who Received a CD34-selected Hematopoietic Stem Cell Transplantation From a Haploidentical Donor

Kiadis Pharma·interventional·Posted Feb 18, 2013·Updated Apr 12, 2021

In Brief

A Phase 2 clinical trial evaluating ATIR for Acute Myeloid Leukemia and 2 related conditions. Completed, enrolled 31 participants across 8 sites in 4 countries.

Detailed Summary

The purpose of this study is to determine whether ATIR is safe and effective in reducing transplant-related mortality and improving overall survival, when infused in patients with a hematologic malignancy following a T-cell depleted stem cell graft from a related haploidentical donor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
CountriesBelgium, Canada, Germany, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 18, 2013
Enrollment StartMar 1, 2013
Primary CompletionJun 1, 2016
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 13.4 years ago

Interventions

ATIRbiological

Donor T-lymphocytes depleted ex vivo of host alloreactive T-cells using photodynamic treatment. Single intravenous infusion with 2x10E6 viable T-cells/kg.