CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
TCR alfa beta T cell depletionbiological
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/NCT01810120
NCT01810120Phase 2Completed

Phase I/II Study of Allogeneic Hematopoietic Stem Cell Transplantation From an HLA-partially Matched Family Donor After TCR Alfa Beta Negative Selection in Pediatric Patients Affected by Hematological Disorders

Mariella Enoc·interventional·Posted Mar 13, 2013·Updated Jan 23, 2017

In Brief

A Phase 2 clinical trial evaluating TCR alfa beta T cell depletion for Acute Lymphoblastic Leukemia and 3 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Allocation: Non-Randomized Endpoint Classification: Safety/Feasibility Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Study to assess the feasibility and safety of the infusion of a T cells receptor (TCR) alfa beta depleted graft in pediatric patients affected by malignant and non-malignant hematological disorders and receiving an Hematopoietic stem cell transplantation (HSCT) from a Human leukocyte antigen (HLA) partially matched family donor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 13, 2013
Enrollment StartJan 1, 2012
Primary CompletionSep 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.3 years ago

Interventions

TCR alfa beta T cell depletionbiological

total nucleated cells from the leukapheresis product will undergo TCR alfa beta negative selection and the product of the depletion will be infused to the patient