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NCT00313586 · OUTCOME

Proportion of Patients With Clinical Response

Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia · Source last updated 2017-02-02

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

Measure
NUMBER
Unit
Proportion of patients
Interval / dispersion
95% Confidence Interval
Time frame
Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2 - 5 years from study entry.

What was measured

Clinical response is defined as a complete response (CR), partial response (PR) or trilineage response (TR) graded according to the following criteria: 1. World Health Organization classification of the acute leukemias and myelodysplastic syndrome (by Bennett) 2. Myelodysplastic syndromes standardized response criteria: further definition (by Cheson et al.) 3. Report of an international working group to standardize response criteria for myelodysplastic syndromes (by Cheson et al.)

Analysis population: All treated patients are included in the analysis.

Groups in this outcome

Arm A (Azacitidine; Non-treatment-induced Cohort)

Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.

Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)

Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.

Arm A (Azacitidine; Treatment-induced Cohort)

Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.

Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)

Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
Arm A (Azacitidine; Non-treatment-induced Cohort)74
Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)75
Arm A (Azacitidine; Treatment-induced Cohort)24
Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)23

Reported measurements

Source class 1
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Azacitidine; Non-treatment-induced Cohort)0.32Not reported0.220.44Not reported
Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)0.27Not reported0.170.39Not reported
Arm A (Azacitidine; Treatment-induced Cohort)0.46Not reported0.260.67Not reported
Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)0.17Not reported0.050.39Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.22
        upper Limit
        0.44
        value
        0.32
      2. group Id
        OG001
        lower Limit
        0.17
        upper Limit
        0.39
        value
        0.27
      3. group Id
        OG002
        lower Limit
        0.26
        upper Limit
        0.67
        value
        0.46
      4. group Id
        OG003
        lower Limit
        0.05
        upper Limit
        0.39
        value
        0.17
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    2. group Id
      OG001
      value
      75
    3. group Id
      OG002
      value
      24
    4. group Id
      OG003
      value
      23
    units
    Participants
description
Clinical response is defined as a complete response (CR), partial response (PR) or trilineage response (TR) graded according to the following criteria: 1. World Health Organization classification of the acute leukemias and myelodysplastic syndrome (by Bennett) 2. Myelodysplastic syndromes standardized response criteria: further definition (by Cheson et al.) 3. Report of an international working group to standardize response criteria for myelodysplastic syndromes (by Cheson et al.)
dispersion Type
95% Confidence Interval
groups
  1. description
    Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
    id
    OG000
    title
    Arm A (Azacitidine; Non-treatment-induced Cohort)
  2. description
    Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
    id
    OG001
    title
    Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)
  3. description
    Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
    id
    OG002
    title
    Arm A (Azacitidine; Treatment-induced Cohort)
  4. description
    Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
    id
    OG003
    title
    Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)
param Type
NUMBER
population Description
All treated patients are included in the analysis.
reporting Status
POSTED
time Frame
Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2 - 5 years from study entry.
title
Proportion of Patients With Clinical Response
type
PRIMARY
unit Of Measure
Proportion of patients

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice