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NCT02367456 · OUTCOME

Number of Participants With Disease-Specific Efficacy Measures in the AML Cohort

A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients · Source last updated 2024-01-19

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
maximum of 23 months

What was measured

Number of participants with partial hematologic recovery (CRh), CR with incomplete blood count recovery (CRi), partial remission (PR), stable disease (SD), and morphologic leukemia free state (MLFS). CRh: neutrophils\>5x10\^8/L, platelets\>5x10\^10/L, BMB\<5%, no peripheral blasts, no blasts with Auer rods, no extramedullary disease (EMD), not qualifying for CR. CRi: neutrophils \<1x10\^9/L or platelets\<1x10\^11/L; BMB \<5%, no peripheral blasts, no blasts with Auer rods; no EMD; neutrophils or platelets not recovered; not qualifying for CRh. PR: neutrophils ≥1x10\^9/L; platelets ≥1x10\^11/L; blasts decreased to 5-25% and ≥50% decrease from pretreatment; blasts≤5% if Auer rod positive. SD: ≥3 months of absence of CR without minimal residual disease (CRMRD-), CR, CRh, CRi, PR, and MLFS, criteria for PD not met. MLFS: neutrophils \<1x10\^9/L and platelets\<1x10\^11/L, BMB\<5%, no blasts with Auer rods; no EMD; neutrophils and platelets not recovered; not qualifying for CRi

Analysis population: The full analysis population included all participants who received at least 1 dose of any study treatment.

Groups in this outcome

AML Cohort

Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.

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

Analysis denominator · Participants

GroupSource count
AML Cohort30

Reported measurements

partial hematologic recovery (CRh)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AML Cohort0Not reportedNot reportedNot reportedNot reported
CR with incomplete blood count recovery (CRi)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AML Cohort1Not reportedNot reportedNot reportedNot reported
partial remission (PR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AML Cohort2Not reportedNot reportedNot reportedNot reported
morphologic leukemia free state (MLFS)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AML Cohort1Not reportedNot reportedNot reportedNot reported
stable disease (SD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AML Cohort6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    partial hematologic recovery (CRh)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    CR with incomplete blood count recovery (CRi)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    partial remission (PR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    morphologic leukemia free state (MLFS)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    stable disease (SD)
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
Number of participants with partial hematologic recovery (CRh), CR with incomplete blood count recovery (CRi), partial remission (PR), stable disease (SD), and morphologic leukemia free state (MLFS). CRh: neutrophils\>5x10\^8/L, platelets\>5x10\^10/L, BMB\<5%, no peripheral blasts, no blasts with Auer rods, no extramedullary disease (EMD), not qualifying for CR. CRi: neutrophils \<1x10\^9/L or platelets\<1x10\^11/L; BMB \<5%, no peripheral blasts, no blasts with Auer rods; no EMD; neutrophils or platelets not recovered; not qualifying for CRh. PR: neutrophils ≥1x10\^9/L; platelets ≥1x10\^11/L; blasts decreased to 5-25% and ≥50% decrease from pretreatment; blasts≤5% if Auer rod positive. SD: ≥3 months of absence of CR without minimal residual disease (CRMRD-), CR, CRh, CRi, PR, and MLFS, criteria for PD not met. MLFS: neutrophils \<1x10\^9/L and platelets\<1x10\^11/L, BMB\<5%, no blasts with Auer rods; no EMD; neutrophils and platelets not recovered; not qualifying for CRi
groups
  1. description
    Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
    id
    OG000
    title
    AML Cohort
param Type
COUNT_OF_PARTICIPANTS
population Description
The full analysis population included all participants who received at least 1 dose of any study treatment.
reporting Status
POSTED
time Frame
maximum of 23 months
title
Number of Participants With Disease-Specific Efficacy Measures in the AML Cohort
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice