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NCT00651261 · OUTCOME

Event- Free Survival

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.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Duration of study (Up to 10 years)

What was measured

Event free survival (EFS) was defined as the time from randomization until the earliest qualifying event, including: failure to obtain a CR on or before 60 days of initiation of protocol therapy; relapse; or death from any cause. Patients alive and event free at the time of analysis were censored on the date of last clinical assessment. The median EFS with 95% CI was estimated using the Kaplan-Meier method. Due to a higher than expected transplant rate, EFS was promoted to be a key secondary endpoint.

Groups in this outcome

Induction and Consolidation Chemotherapy Plus Midostaurin

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.

Induction and Consolidation Chemotherapy Plus Placebo

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Induction and Consolidation Chemotherapy Plus Midostaurin360
Induction and Consolidation Chemotherapy Plus Placebo357

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Induction and Consolidation Chemotherapy Plus Midostaurin8.2Not reported5.410.7Not reported
Induction and Consolidation Chemotherapy Plus Placebo3.0Not reported1.95.9Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.93
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0024
    param Type
    Hazard Ratio (HR)
    param Value
    0.78
    statistical Method
    1-sided stratified log rank
Complete source fields
analyses
  1. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.93
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0024
    param Type
    Hazard Ratio (HR)
    param Value
    0.78
    statistical Method
    1-sided stratified log rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.4
        upper Limit
        10.7
        value
        8.2
      2. group Id
        OG001
        lower Limit
        1.9
        upper Limit
        5.9
        value
        3.0
denoms
  1. counts
    1. group Id
      OG000
      value
      360
    2. group Id
      OG001
      value
      357
    units
    Participants
description
Event free survival (EFS) was defined as the time from randomization until the earliest qualifying event, including: failure to obtain a CR on or before 60 days of initiation of protocol therapy; relapse; or death from any cause. Patients alive and event free at the time of analysis were censored on the date of last clinical assessment. The median EFS with 95% CI was estimated using the Kaplan-Meier method. Due to a higher than expected transplant rate, EFS was promoted to be a key secondary endpoint.
dispersion Type
95% Confidence Interval
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
    OG000
    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
    OG001
    title
    Induction and Consolidation Chemotherapy Plus Placebo
param Type
MEDIAN
reporting Status
POSTED
time Frame
Duration of study (Up to 10 years)
title
Event- Free Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice