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LEAP: Novel Therapeutics vs Azacitidine in Older AML/MDS

NCT03092674Phase 3Completed

Sponsor: National Cancer Institute
Start: Feb 2018
Primary completion: Aug 2023
Modality: Small Molecules, Monoclonal Antibodies
Countries: 1

Overview

Phase 3, randomised, open-label trial of nivolumab, midostaurin, decitabine and cytarabine in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) (4 arms), sponsored by National Cancer Institute. Primary endpoints: Overall Survival (Phase II) up to 5 years and Overall Survival (Phase III) up to 5 years. Started Feb 2018; status: completed.

Drugs

nivolumabmidostaurindecitabinecytarabine

Conditions

acute myeloid leukemia (AML)myelodysplastic syndrome (MDS)

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