Participant flow

Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia · Source last updated 2021-08-18

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

groups

1. description

   Patients will receive daunorubicin 60 mg/m\^2 by IV push days 1-3 plus cytarabine 200 mg/m\^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\^2) days 1, 3, \& 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.

   id

   FG000

   title

   Induction and Consolidation Chemotherapy Plus Midostaurin

2. description

   Patients will receive daunorubicin 60 mg/m\^2 by IV push days 1-3 plus cytarabine 200 mg/m\^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\^2) days 1, 3, \& 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.

   id

   FG001

   title

   Induction and Consolidation Chemotherapy Plus Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         32

      2. group Id

         FG001

         num Subjects

         22

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         18

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         40

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         35

      type

      Induction failure

   5. reasons

      1. group Id

         FG000

         num Subjects

         58

      2. group Id

         FG001

         num Subjects

         58

      type

      Disease progression

   6. reasons

      1. group Id

         FG000

         num Subjects

         109

      2. group Id

         FG001

         num Subjects

         107

      type

      Alternative therapy

   7. reasons

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         23

      type

      Other disease or participant decisions

   8. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         3

      type

      Never treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         360

      2. group Id

         FG001

         num Subjects

         357

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         69

      2. group Id

         FG001

         num Subjects

         51

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         291

      2. group Id

         FG001

         num Subjects

         306

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Between May 2008 and October 2001, 3,277 participants were pre-registered. Of those, 900 participants had a documented FLT3 mutation. 717 participants were enrolled onto this study.

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Preserved source evidence · Not medical advice