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NCT02668653 · OUTCOME

Number of Participants Achieving Composite CR With FLT3-ITD Minimal Residual Disease Negativity at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia

Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) · Source last updated 2024-08-06

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Approximately Cycle 1 Day 21 (Induction phase) to end of Induction phase, up to approximately 120 days (each Induction cycle is up to 60 days)

What was measured

Composite complete remission (CRc) is defined as \<5% blasts, \>1000 neutrophils, \>100,000 platelets, and other \[defined as absence of extramedullary disease \[EMD\], blasts with rods, and leukemic blasts\], or CR with incomplete neutrophil or platelet recovery (CRi). Minimal or measurable residual disease is the presence of a small number of leukemic cells in the bone marrow of patients with AML below the level of detection using conventional morphologic assessment.

Analysis population: Composite complete remission (CRc) rate was assessed in the Intent-to-Treat Analysis Set.

Groups in this outcome

Quizartinib

Participants who were randomized to receive quizartinib treatment regimen.

Placebo

Participants who were randomized to receive placebo treatment regimen.

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

Analysis denominator · Participants

GroupSource count
Quizartinib268
Placebo271

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Quizartinib66Not reportedNot reportedNot reportedNot reported
Placebo58Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        66
      2. group Id
        OG001
        value
        58
denoms
  1. counts
    1. group Id
      OG000
      value
      268
    2. group Id
      OG001
      value
      271
    units
    Participants
description
Composite complete remission (CRc) is defined as \<5% blasts, \>1000 neutrophils, \>100,000 platelets, and other \[defined as absence of extramedullary disease \[EMD\], blasts with rods, and leukemic blasts\], or CR with incomplete neutrophil or platelet recovery (CRi). Minimal or measurable residual disease is the presence of a small number of leukemic cells in the bone marrow of patients with AML below the level of detection using conventional morphologic assessment.
groups
  1. description
    Participants who were randomized to receive quizartinib treatment regimen.
    id
    OG000
    title
    Quizartinib
  2. description
    Participants who were randomized to receive placebo treatment regimen.
    id
    OG001
    title
    Placebo
param Type
COUNT_OF_PARTICIPANTS
population Description
Composite complete remission (CRc) rate was assessed in the Intent-to-Treat Analysis Set.
reporting Status
POSTED
time Frame
Approximately Cycle 1 Day 21 (Induction phase) to end of Induction phase, up to approximately 120 days (each Induction cycle is up to 60 days)
title
Number of Participants Achieving Composite CR With FLT3-ITD Minimal Residual Disease Negativity at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice