Participant flow

Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation · Source last updated 2026-06-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants received AG-120 500 mg orally, once daily (QD) in combination with azacitidine 75 milligrams per square meter per day (mg/m\^2/day) subcutaneously (SC) or intravenously (IV), on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.

   id

   FG000

   title

   AG-120 + Azacitidine

2. description

   Participants received AG-120 matching placebo orally, QD in combination with azacitidine 75 mg/m\^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.

   id

   FG001

   title

   Placebo + Azacitidine

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         46

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         4

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         38

      2. group Id

         FG001

         num Subjects

         23

      type

      Ongoing at Data Cut-off Date: 18 March 2021

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         72

      2. group Id

         FG001

         num Subjects

         74

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         71

      2. group Id

         FG001

         num Subjects

         73

      comment

      Safety Analysis Set (SAS) included all participants who received at least 1 dose of the study treatment.

      type

      Safety Analysis Set

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         72

      2. group Id

         FG001

         num Subjects

         74

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 146 participants with previously untreated isocitrate dehydrogenase 1 mutation-positive (IDH1m) acute myeloid leukemia (AML) were randomized into a 1:1 ratio to receive ivosidenib (AG-120) or AG-120 matched placebo in combination with azacitidine.

recruitment Details

Participants took part in the study at 199 investigational sites from 19 March 2018 to 18 March 2021 (data cut off date). This study is ongoing. Results collected through data cut off date, 18 March 2021 are being reported.

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Preserved source evidence · Not medical advice