Participant flow

Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia · Source last updated 2026-07-23

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

groups

1. description

   Induction: Daunorubicin, cytarabine and gilteritinib. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and gilteritinib. Gilteritinib: Induction: 120 mg orally daily x 14 days starting on day 8 Consolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles

   id

   FG000

   title

   Arm A

2. description

   Induction: Daunorubicin, cytarabine and midostaurin. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and midostaurin. Midostaurin: Induction: 50 mg orally twice daily x 14 days beginning on day 8 Consolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles

   id

   FG001

   title

   Arm B

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         2

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         10

      type

      Lack of Efficacy

   4. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         11

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      type

      Protocol Violation

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         10

      type

      Withdrawal by Subject

   7. reasons

      1. group Id

         FG000

         num Subjects

         55

      2. group Id

         FG001

         num Subjects

         44

      type

      Intercurrent illness, Recurrence of disease, Subject proceeded to transplant or non-protocol therapy

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         90

      2. group Id

         FG001

         num Subjects

         87

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         6

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         80

      2. group Id

         FG001

         num Subjects

         81

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

All randomized, eligible, and treated patients. 3 patients passed away/withdrew before induction. 1 patient determined to not have the diagnosis to meet the eligibility criteria and was removed from the study (181 consented).

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice