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NCT02281084 · OUTCOME

Percentage of Participants Who Progressed to Acute Myelogenous Leukemia (AML)

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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
From first dose and until death, loss to follow-up, withdrawal of consent for further data collection (Up to 91 months)

What was measured

For all participants who received at least one dose of study drug, continuous monitoring for progression to AML occurred in the post treatment follow up period.

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

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 Azacitidine32
Progressive Disease (PD) Cohort: Oral Azacitidine22
Stable Disease Cohort: Oral Azacitidine and Durvalumab6
Progressive Disease Cohort: Oral Azacitidine and Durvalumab5

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stable Disease (SD) Cohort: Oral Azacitidine31.3Not reportedNot reportedNot reportedNot reported
Progressive Disease (PD) Cohort: Oral Azacitidine18.2Not reportedNot reportedNot reportedNot reported
Stable Disease Cohort: Oral Azacitidine and Durvalumab33.3Not reportedNot reportedNot reportedNot reported
Progressive Disease Cohort: Oral Azacitidine and Durvalumab60.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        31.3
      2. group Id
        OG001
        value
        18.2
      3. group Id
        OG002
        value
        33.3
      4. group Id
        OG003
        value
        60.0
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    2. group Id
      OG001
      value
      22
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      5
    units
    Participants
description
For all participants who received at least one dose of study drug, continuous monitoring for progression to AML occurred in the post treatment follow up period.
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
NUMBER
population Description
The ITT population included all enrolled participants who received at least one dose of IP.
reporting Status
POSTED
time Frame
From first dose and until death, loss to follow-up, withdrawal of consent for further data collection (Up to 91 months)
title
Percentage of Participants Who Progressed to Acute Myelogenous Leukemia (AML)
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice