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Allogeneic Immunotherapy for Hematological Malignancies by Selective Depletion of Regulatory T Cells — DLI-Boost  

Hematological Malignancies Clinical Trial

Official title:
Allogeneic Immunotherapy for Hematological Malignancies by Selective Depletion of Regulatory T Cells: A Confirmatory, Randomized, Double Blinded Trial

Clinical Trial Summary

The investigators have previously shown the absence of toxicity of Treg-depleted-DLI and the possibility to triggering alloreactivity (GVHD/GVT) in relapsing patients dealing with hematological malignancies who had never shown any signs of GVHD after transplant or after one or more DLI. The Investigators, we plan to demonstrate the benefit of Treg-depleted DLI as compared to the reference treatment of relapse in hematological malignancies after allogeneic HSCT which is currently based on standard DLI

Clinical Trial Description

This clinical trial is designed to demonstrate the benefit of Treg-depleted DLI as compared to the reference treatment of relapse in hematological malignancies after allogeneic HSCT which is currently based on standard DLI. Patients who have never shown any signs of GVHD and for which one (or more) unmanipulated DLI have been ineffective. Those patients will receive a subsequent DLI, which will be either unmanipulated (control arm) or Treg depleted (experimental arm) after a randomization. In both cases, the second DLI will be immediately preceded by a lymphodepleting treatment based on cyclophosphamide and fludarabine association. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03236129
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Florence BECKERICH, MD
Phone (0)1 49 81 20 57
Email florence.beckerich@aphp.fr
Status Recruiting
Phase Phase 3
Start date February 22, 2018
Completion date February 2026
View Details
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