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Efficacy and Safety of a Donor Lymphocyte Preparation Depleted of Functional Host Alloreactive T-cells (ATIR) in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor

NCT00967343 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-06-14

Study results available
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Summary

The purpose of this study is to determine whether the administration of a donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR) after a T-cell depleted stem cell transplant from a related, haploidentical donor enhances survival by improving the immune effect against infections while preventing graft-versus-host disease .

Conditions

Interventions

BIOLOGICAL

Donor lymphocyte preparation depleted of host functional alloreactive T-cells

Single intravenous infusion with 2x10E6 T-cells/kg

Sponsors & Collaborators

  • Kiadis Pharma

    lead INDUSTRY

Principal Investigators

  • Stephan Mielke, MD · Julius Maximilian University of Würzburg, Germany

  • Denis-Claude Roy, MD · Maisonneuve-Rosemont Hospital, Montreal, Canada

  • Andrea Velardi, MD · University Of Perugia

  • Katy Rezvani, MD PhD · Hammersmith Hospital, London, United Kingdom

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00967343 on ClinicalTrials.gov