Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02421939 · OUTCOME

Percentage of Participants Who Achieved Transfusion Conversion and Maintenance

A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation · Source last updated 2025-12-04

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
From 29 days post first dose of study drug until last dose(median treatment duration was (126.00 [4.0, 885.0])

What was measured

Transfusion conversion \& maintenance rate was defined for gilteritinib arm. Participants were classified as transfusion independent if there were no RBC or platelet transfusions within 28 days prior to the first dose to 28 days after the first dose; otherwise they were classified as transfusion dependent at baseline. Participants were considered independent postbaseline if they had 1 consecutive 8 week period without any RBC or platelet transfusion from 29 days after the first dose until the last dose date. For participants who were on treatment ≤ 4 weeks or \> 4 weeks but \< 12 weeks and there was no RBC or platelet transfusion within postbaseline period, they were considered not evaluable; otherwise, they were considered postbaseline transfusion dependent. Transfusion conversion rate was defined for participants who had evaluable postbaseline transfusion status. Transfusion status (independent vs. dependent) at baseline and postbaseline was reported in a 2 by 2 contingency table.

Analysis population: The analysis population was the ITT, with participants who had evaluable postbaseline transfusion status.

Groups in this outcome

Gilteritinib

Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment.

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

Analysis denominator · Participants

GroupSource count
Gilteritinib246

Reported measurements

Baseline Independent/ Post baseline Independent
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gilteritinib59.2Not reportedNot reportedNot reportedNot reported
Baseline Independent/Post baseline Dependent
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gilteritinib24.5Not reportedNot reportedNot reportedNot reported
Baseline Independent/Post baseline Not Evaluable
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gilteritinib16.3Not reportedNot reportedNot reportedNot reported
Baseline Dependent/Post baseline Independent
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gilteritinib34.5Not reportedNot reportedNot reportedNot reported
Baseline Dependent/Post baseline Dependent
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gilteritinib55.8Not reportedNot reportedNot reportedNot reported
Baseline Dependent/Post baseline Not Evaluable
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gilteritinib9.6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        59.2
    title
    Baseline Independent/ Post baseline Independent
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        24.5
    title
    Baseline Independent/Post baseline Dependent
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        16.3
    title
    Baseline Independent/Post baseline Not Evaluable
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        34.5
    title
    Baseline Dependent/Post baseline Independent
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        55.8
    title
    Baseline Dependent/Post baseline Dependent
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        9.6
    title
    Baseline Dependent/Post baseline Not Evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      246
    units
    Participants
description
Transfusion conversion \& maintenance rate was defined for gilteritinib arm. Participants were classified as transfusion independent if there were no RBC or platelet transfusions within 28 days prior to the first dose to 28 days after the first dose; otherwise they were classified as transfusion dependent at baseline. Participants were considered independent postbaseline if they had 1 consecutive 8 week period without any RBC or platelet transfusion from 29 days after the first dose until the last dose date. For participants who were on treatment ≤ 4 weeks or \> 4 weeks but \< 12 weeks and there was no RBC or platelet transfusion within postbaseline period, they were considered not evaluable; otherwise, they were considered postbaseline transfusion dependent. Transfusion conversion rate was defined for participants who had evaluable postbaseline transfusion status. Transfusion status (independent vs. dependent) at baseline and postbaseline was reported in a 2 by 2 contingency table.
groups
  1. description
    Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment.
    id
    OG000
    title
    Gilteritinib
param Type
NUMBER
population Description
The analysis population was the ITT, with participants who had evaluable postbaseline transfusion status.
reporting Status
POSTED
time Frame
From 29 days post first dose of study drug until last dose(median treatment duration was (126.00 [4.0, 885.0])
title
Percentage of Participants Who Achieved Transfusion Conversion and Maintenance
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice