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NCT02113982 · OUTCOME

Duration of CR in First-line BPDCN, R/R BPDCN and AML

Tagraxofusp in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia · Source last updated 2024-08-01

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
at pre-defined treatment cycle intervals from randomization up to disease progression, up to 5 years

What was measured

Duration of complete response (CR) defined as the time from when the criteria are first met for CR+CRc (whichever was recorded first) until the date that the criteria for relapse after CR+CRc are met, according to the previously reported criteria for CR and CRc and following criteria of relapse after CR+CRc (Cheson BD et al. J Clin Oncol 2007;25:579-586.): Marrow: blast percentage \>5% (if no peripheral blasts, then confirmation aspirate required ≥ 1week later) Peripheral blood: presence of leukemic blasts Skin: increase in skin score greater than the sum of nadir plus 50% baseline score Nodal masses: appearance of a new lesion(s) \>1.5 cm in any axis, ≥50% increase from nadir in SPD of more than one node, or ≥50% increase from nadir in longest diameter of a previously identified node \>1cm in short axis Spleen, liver: \>50% increase from nadir in the SPD of any previous lesions

Analysis population: Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML

Groups in this outcome

First-Line BPDCN

First-Line BPDCN patients enrolled across stages

R/R BPDCN

R/R BPDCN enrolled across stages

Acute Myeloid Leukemia

AML patients enrolled in stages 1 and 2

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

Analysis denominator · Participants

GroupSource count
First-Line BPDCN65
R/R BPDCN19
Acute Myeloid Leukemia36

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
First-Line BPDCN24.9Not reported0.9957.36Not reported
R/R BPDCN3.6Not reported3.0213.93Not reported
Acute Myeloid Leukemia8.6Not reportedNANA1 participant only experienced CR
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.99
        upper Limit
        57.36
        value
        24.9
      2. group Id
        OG001
        lower Limit
        3.02
        upper Limit
        13.93
        value
        3.6
      3. comment
        1 participant only experienced CR
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        8.6
denoms
  1. counts
    1. group Id
      OG000
      value
      65
    2. group Id
      OG001
      value
      19
    3. group Id
      OG002
      value
      36
    units
    Participants
description
Duration of complete response (CR) defined as the time from when the criteria are first met for CR+CRc (whichever was recorded first) until the date that the criteria for relapse after CR+CRc are met, according to the previously reported criteria for CR and CRc and following criteria of relapse after CR+CRc (Cheson BD et al. J Clin Oncol 2007;25:579-586.): Marrow: blast percentage \>5% (if no peripheral blasts, then confirmation aspirate required ≥ 1week later) Peripheral blood: presence of leukemic blasts Skin: increase in skin score greater than the sum of nadir plus 50% baseline score Nodal masses: appearance of a new lesion(s) \>1.5 cm in any axis, ≥50% increase from nadir in SPD of more than one node, or ≥50% increase from nadir in longest diameter of a previously identified node \>1cm in short axis Spleen, liver: \>50% increase from nadir in the SPD of any previous lesions
dispersion Type
Full Range
groups
  1. description
    First-Line BPDCN patients enrolled across stages
    id
    OG000
    title
    First-Line BPDCN
  2. description
    R/R BPDCN enrolled across stages
    id
    OG001
    title
    R/R BPDCN
  3. description
    AML patients enrolled in stages 1 and 2
    id
    OG002
    title
    Acute Myeloid Leukemia
param Type
MEDIAN
population Description
Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML
reporting Status
POSTED
time Frame
at pre-defined treatment cycle intervals from randomization up to disease progression, up to 5 years
title
Duration of CR in First-line BPDCN, R/R BPDCN and AML
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice