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OPTISAGE: Thymoglobulin versus Grafalon for GVHD prophylaxis after matched unrelated donor allo-HSCT in older AML/MDS patients

2023-504555-27-00Phase 3Authorised

Sponsor
Assistance publique - Hôpitaux de Paris
Start
Sep 2023
Modality
Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
Countries
2
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Overview

Phase 3, randomised, open-label trial of antithymocyte globulin and antithymocyte globulin rabbit in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) (2 arms), sponsored by Assistance publique - Hôpitaux de Paris. Primary endpoint: Incidence of grade II-IV acute graft-versus-host disease by day 100. Planned start Sep 2023; status: authorised.

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Drugs

antithymocyte globulinantithymocyte globulin rabbit
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Conditions

acute myeloid leukemia (AML)myelodysplastic syndrome (MDS)

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