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
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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