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NCT02113982 · OUTCOME

CR Rate 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
NUMBER
Unit
percentage of evaluable patients
Interval / dispersion
95% Confidence Interval
Time frame
at pre-defined treatment cycle intervals from randomization up to disease progression, up to 5 years

What was measured

CR rate, defined as the percentage of patients who achieved CR+ CR with minimal residual skin abnormality (CRc) after treatment with Tagraxofusp. CR criteria according to Cheson BD et al, The International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-586: Marrow: normalization of blast percentage (≤5%) Peripheral blood: normalization of neutrophil count (≥ 1,000/µL) and platelet count (≥ 100,000/µL) - absence of leukemic blasts Skin: 100% clearance of all skin lesions from baseline; no new lesions in patients without lesions at baseline Nodal masses: regression to normal size on CT Spleen, liver: not palpable, nodules disappeared CRc criteria: all the above except for skin: marked clearance of all skin lesions from baseline; residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed)

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 patients enrolled across stages

Acute Myeloid Leukemia

AML patients enrolled in stage 1-2

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 percentage of evaluable patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
First-line BPDCN56.9Not reported4469.2Not reported
R/R BPDCN15.8Not reported3.439.6Not reported
Acute Myeloid Leukemia3Not reported0.114.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        44
        upper Limit
        69.2
        value
        56.9
      2. group Id
        OG001
        lower Limit
        3.4
        upper Limit
        39.6
        value
        15.8
      3. group Id
        OG002
        lower Limit
        0.1
        upper Limit
        14.2
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      65
    2. group Id
      OG001
      value
      19
    3. group Id
      OG002
      value
      36
    units
    Participants
description
CR rate, defined as the percentage of patients who achieved CR+ CR with minimal residual skin abnormality (CRc) after treatment with Tagraxofusp. CR criteria according to Cheson BD et al, The International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-586: Marrow: normalization of blast percentage (≤5%) Peripheral blood: normalization of neutrophil count (≥ 1,000/µL) and platelet count (≥ 100,000/µL) - absence of leukemic blasts Skin: 100% clearance of all skin lesions from baseline; no new lesions in patients without lesions at baseline Nodal masses: regression to normal size on CT Spleen, liver: not palpable, nodules disappeared CRc criteria: all the above except for skin: marked clearance of all skin lesions from baseline; residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed)
dispersion Type
95% Confidence Interval
groups
  1. description
    First-Line BPDCN patients enrolled across stages
    id
    OG000
    title
    First-line BPDCN
  2. description
    R/R BPDCN patients enrolled across stages
    id
    OG001
    title
    R/R BPDCN
  3. description
    AML patients enrolled in stage 1-2
    id
    OG002
    title
    Acute Myeloid Leukemia
param Type
NUMBER
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
CR Rate in First-line BPDCN, R/R BPDCN and AML
type
SECONDARY
unit Of Measure
percentage of evaluable patients

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

Preserved source evidence · Not medical advice