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NCT01522976 · OUTCOME

Response Rate (Phase II)

Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia · Source last updated 2026-09-09

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

Measure
NUMBER
Unit
percentage of patients having a response
Interval / dispersion
95% Confidence Interval
Time frame
Up to 5 years

What was measured

A response is any of complete hematological remission, partial remission, or hematologic improvement.

Analysis population: Analysis includes eligible patients only.

Groups in this outcome

Arm 1: Azacitidine/Lenalidomide

Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO

Arm 2: Azacitidine

Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV

Arm 3: Azacitidine/Vorinostat

Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO

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 1: Azacitidine/Lenalidomide93
Arm 2: Azacitidine92
Arm 3: Azacitidine/Vorinostat92

Reported measurements

Source class 1
Values in percentage of patients having a response · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm 1: Azacitidine/Lenalidomide49Not reported3960Not reported
Arm 2: Azacitidine38Not reported2849Not reported
Arm 3: Azacitidine/Vorinostat27Not reported1837Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39
        upper Limit
        60
        value
        49
      2. group Id
        OG001
        lower Limit
        28
        upper Limit
        49
        value
        38
      3. group Id
        OG002
        lower Limit
        18
        upper Limit
        37
        value
        27
denoms
  1. counts
    1. group Id
      OG000
      value
      93
    2. group Id
      OG001
      value
      92
    3. group Id
      OG002
      value
      92
    units
    Participants
description
A response is any of complete hematological remission, partial remission, or hematologic improvement.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO
    id
    OG000
    title
    Arm 1: Azacitidine/Lenalidomide
  2. description
    Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
    id
    OG001
    title
    Arm 2: Azacitidine
  3. description
    Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
    id
    OG002
    title
    Arm 3: Azacitidine/Vorinostat
param Type
NUMBER
population Description
Analysis includes eligible patients only.
reporting Status
POSTED
time Frame
Up to 5 years
title
Response Rate (Phase II)
type
PRIMARY
unit Of Measure
percentage of patients having a response

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

Preserved source evidence · Not medical advice