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NCT02113982 · OUTCOME

MTD (Stage 1)

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
µg/kg/day
Interval / dispersion
Not reported
Time frame
21-day period after the first dose (cycle 1)

What was measured

Maximum tolerated dose (MTD) in both patients with BPDCN and AML. MTD defined as the highest dose level where less than 2/3 or 2/6 patients experienced a DLT

Analysis population: Patients with First-line Blastic Plasmacytoid Dendritic Cell Neoplasm, R/R Blastic Plasmacytoid Dendritic Cell Neoplasm and Acute Myeloid Leukemia participating to stage 1 (dose-escalation)

Groups in this outcome

First-line BPDCN

First-line BPDCN participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day or 12 µg/kg/day in stage 1

R/R BPDCN

R/R BPDCN who received at least 1 dose of Tagraxofusp either at 12 µg/kg/day in Stage 1

Acute Myeloid Leukemia

AML participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day, 9 µg/kg/day, 12 µg/kg/day or 16 µg/kg/day in Stage 1

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 BPDCN6
R/R BPDCN3
Acute Myeloid Leukemia14

Reported measurements

Source class 1
Values in µg/kg/day · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
First-line BPDCN12Not reportedNot reportedNot reportedNot reported
R/R BPDCN12Not reportedNot reportedNot reportedNot reported
Acute Myeloid Leukemia16Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        16
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      14
    units
    Participants
description
Maximum tolerated dose (MTD) in both patients with BPDCN and AML. MTD defined as the highest dose level where less than 2/3 or 2/6 patients experienced a DLT
groups
  1. description
    First-line BPDCN participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day or 12 µg/kg/day in stage 1
    id
    OG000
    title
    First-line BPDCN
  2. description
    R/R BPDCN who received at least 1 dose of Tagraxofusp either at 12 µg/kg/day in Stage 1
    id
    OG001
    title
    R/R BPDCN
  3. description
    AML participants who received at least 1 dose of Tagraxofusp either at 7µg/kg/day, 9 µg/kg/day, 12 µg/kg/day or 16 µg/kg/day in Stage 1
    id
    OG002
    title
    Acute Myeloid Leukemia
param Type
NUMBER
population Description
Patients with First-line Blastic Plasmacytoid Dendritic Cell Neoplasm, R/R Blastic Plasmacytoid Dendritic Cell Neoplasm and Acute Myeloid Leukemia participating to stage 1 (dose-escalation)
reporting Status
POSTED
time Frame
21-day period after the first dose (cycle 1)
title
MTD (Stage 1)
type
PRIMARY
unit Of Measure
µg/kg/day

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

Preserved source evidence · Not medical advice