Dose-ranging Study of a Single Administration of T-cell Add-back Depleted of Host Alloreactive Cells in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor

NCT00993486 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2013-06-20

No results posted yet for this study

Summary

The purpose of this study is to determine the maximum tolerated dose and evaluate the safety of the administration of donor lymphocytes depleted of alloreactive T-cells following a stem cell transplant from a related, haploidentical donor, in patients with severe hematologic malignancies.

Conditions

Interventions

BIOLOGICAL

Donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR)

Single intravenous infusion

Sponsors & Collaborators

  • Kiadis Pharma

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2008-10-31
Completion
2013-04-30

Countries

  • Canada

Study Locations

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Entities

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 NCT00993486 on ClinicalTrials.gov