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Phase II TMLI + fludarabine + melphalan conditioning for allo-HSCT in high-risk MDS/AML

2024-514483-11-00Phase 2Authorised

Sponsor
Fundación Pública Andaluza para la Gestión de la Investigación
Start
Nov 2024
Modality
RNA-Targeting Small Molecules → Nucleic Acid-Directed Small Molecules → Small Molecules, Small Molecules, Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules
Countries
1
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Overview

Phase 2, open-label, single-arm trial of melphalan, fludarabine, cyclophosphamide, tacrolimus and mycophenolate mofetil in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), sponsored by Fundación Pública Andaluza para la Gestión de la Investigación. Primary endpoints: Toxicity (safety run-in segment) and Progression-free survival at 2 years. Planned start Nov 2024; status: authorised.

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Drugs

melphalanfludarabinecyclophosphamidetacrolimusmycophenolate mofetil
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Conditions

myelodysplastic syndrome (MDS)acute myeloid leukemia (AML)

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