Study on the Safety and Effectiveness of Two Drug Combinations with Azacitidine for Newly Diagnosed Acute Myeloid Leukemia with IDH Mutations

Sponsor: Celgene

Sponsor score: 60

ClinicalTrials ID:NCT02677922

This clinical trial is testing two different drug combinations with azacitidine to see if they are safe and effective for patients with newly diagnosed acute myeloid leukemia (AML) that has specific IDH mutations and who cannot undergo intensive chemotherapy.

Patient Parameters

Program Overview

The study aims to find the best dose for two drug combinations, AG-120 with azacitidine and AG-221 with azacitidine, and to evaluate their safety and effectiveness compared to azacitidine alone in patients with acute myeloid leukemia (AML) that has IDH1 or IDH2 mutations.

Eligibility Criteria

Inclusion Criteria

  • Have been newly diagnosed with acute myeloid leukemia (AML), either as a primary condition or as a progression from other blood disorders like myelodysplastic syndrome (MDS) or myeloproliferative neoplasms (MPN).
  • Have at least 20% leukemic blasts in the bone marrow.
  • Have an ECOG performance status of 0, 1, or 2, indicating full activity or some restriction in physically strenuous activity.
  • Agree to undergo repeated bone marrow tests.

Exclusion Criteria

  • Have or are suspected to have acute promyelocytic leukemia based on specific tests.
  • Have AML that developed from chronic myelogenous leukemia (CML).
  • Have previously received treatments targeting IDH1 or IDH2 mutations.
  • Have or are suspected to have leukemia affecting the central nervous system (CNS). Testing for CNS involvement is only needed if there are signs of CNS leukemia during screening.

Locations

FACILITYZIPCITYSTATE
Local Institution - 10591010-301DuarteCalifornia
Local Institution - 10706510New HavenConnecticut
Local Institution - 10860611ChicagoIllinois
Local Institution - 10360637ChicagoIllinois
Local Institution - 10202114BostonMassachusetts
Beth Israel Deaconess Medical Center02115BostonMassachusetts
Local Institution - 90202115BostonMassachusetts
Local Institution - 10610065New YorkNew York
Local Institution - 11075390-85520DallasTexas

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