NCT03236129

Allogeneic Immunotherapy for Hematological Malignancies by Selective Depletion of Regulatory T Cells

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Hematological Malignancies
• Regulatory T Cell Depletion
• Relapse

Interventions

Type	Name	Description
PROCEDURE	T-reg depleted DLI	The patients in the experimental arm benefit of a DLI depleted from regulatory T lymphocytes
PROCEDURE	Standard DLI	The patients in this arm benefit of a standard DLI.

Timeline

• Start date: 2018-02-22
• Primary completion: 2025-02-01
• Completion: 2026-02-01
• First posted: 2017-08-01
• Last updated: 2023-12-18

Locations

1 site across 1 country: France