Spots Global Cancer Trial Database for Allogeneic Immunotherapy for Hematological Malignancies by Selective Depletion of Regulatory T Cells

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Trial Identification

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

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

Study ID: NCT03236129

Conditions

Hematological Malignancies

Regulatory T Cell Depletion

Relapse

Interventions

T-reg depleted DLI

Standard DLI

Study Description

Brief 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.