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NCT02281084 · OUTCOME

Kaplan Meier Estimate of Duration of First Response

Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes · Source last updated 2024-10-04

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
Response was assessed every 2 cycles following treatment during the first 6 cycles, then every 3 cycles thereafter; median duration of treatment = 5.26 and 3.81 months for SD/PD for oral AZA arms respectively, and 1.84 months for AZA and Durva SD/PD arms

What was measured

Duration of hematologic response and/or improvement was defined as the time from the date response or improvement was first observed to the date of documented relapse or disease progression as defined by the modified IWG 2006 criteria. Particpants who maintained hematologic response and/or improvement through the end of the treatment period were censored as the date of treatment discontinuation or death, whichever occurred first.

Analysis population: The ITT population included all enrolled participants who received at least one dose of IP; participants who achieved a response.

Groups in this outcome

Stable Disease (SD) Cohort: Oral Azacitidine

Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.

Progressive Disease (PD) Cohort: Oral Azacitidine

Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.

Stable Disease Cohort: Oral Azacitidine and Durvalumab

Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.

Progressive Disease Cohort: Oral Azacitidine and Durvalumab

Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.

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

Analysis denominator · Participants

GroupSource count
Stable Disease (SD) Cohort: Oral Azacitidine3
Progressive Disease (PD) Cohort: Oral Azacitidine2
Stable Disease Cohort: Oral Azacitidine and Durvalumab1
Progressive Disease Cohort: Oral Azacitidine and Durvalumab0

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Stable Disease (SD) Cohort: Oral AzacitidineNANot reported9.24NACould not be estimated due to the insufficient number of events.
Progressive Disease (PD) Cohort: Oral AzacitidineNANot reportedNANACould not be estimated due to the insufficient number of events.
Stable Disease Cohort: Oral Azacitidine and DurvalumabNANot reportedNANACould not be estimated due to the insufficient number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Could not be estimated due to the insufficient number of events.
        group Id
        OG000
        lower Limit
        9.24
        upper Limit
        NA
        value
        NA
      2. comment
        Could not be estimated due to the insufficient number of events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        Could not be estimated due to the insufficient number of events.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      0
    units
    Participants
description
Duration of hematologic response and/or improvement was defined as the time from the date response or improvement was first observed to the date of documented relapse or disease progression as defined by the modified IWG 2006 criteria. Particpants who maintained hematologic response and/or improvement through the end of the treatment period were censored as the date of treatment discontinuation or death, whichever occurred first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    OG000
    title
    Stable Disease (SD) Cohort: Oral Azacitidine
  2. description
    Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    OG001
    title
    Progressive Disease (PD) Cohort: Oral Azacitidine
  3. description
    Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    OG002
    title
    Stable Disease Cohort: Oral Azacitidine and Durvalumab
  4. description
    Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    OG003
    title
    Progressive Disease Cohort: Oral Azacitidine and Durvalumab
param Type
MEDIAN
population Description
The ITT population included all enrolled participants who received at least one dose of IP; participants who achieved a response.
reporting Status
POSTED
time Frame
Response was assessed every 2 cycles following treatment during the first 6 cycles, then every 3 cycles thereafter; median duration of treatment = 5.26 and 3.81 months for SD/PD for oral AZA arms respectively, and 1.84 months for AZA and Durva SD/PD arms
title
Kaplan Meier Estimate of Duration of First Response
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice