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NCT03386513 · OUTCOME

Percentage of Participants With Post-baseline Transfusion Independence in BPDCN Participants

Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN · Source last updated 2026-09-04

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
95% Confidence Interval
Time frame
Up to approximately 81 months

What was measured

Post-baseline transfusion independence (red blood cell \[RBC\] and platelet transfusion independence) was defined as any 56-day period after Cycle 1 Day 1 in which the participant did not receive either a RBC or platelet transfusion.

Analysis population: The safety population included all participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = BPDCN participants. Per protocol, this endpoint evaluated only BPDCN participants, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.

Groups in this outcome

BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg

Participants received IMGN632 via IV infusion on Day 1 of each 21-day cycle.

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

Analysis denominator · Participants

GroupSource count
BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg84

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg63.1Not reported51.8773.37Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        51.87
        upper Limit
        73.37
        value
        63.1
denoms
  1. counts
    1. group Id
      OG000
      value
      84
    units
    Participants
description
Post-baseline transfusion independence (red blood cell \[RBC\] and platelet transfusion independence) was defined as any 56-day period after Cycle 1 Day 1 in which the participant did not receive either a RBC or platelet transfusion.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received IMGN632 via IV infusion on Day 1 of each 21-day cycle.
    id
    OG000
    title
    BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg
param Type
NUMBER
population Description
The safety population included all participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = BPDCN participants. Per protocol, this endpoint evaluated only BPDCN participants, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.
reporting Status
POSTED
time Frame
Up to approximately 81 months
title
Percentage of Participants With Post-baseline Transfusion Independence in BPDCN Participants
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Independent clinical review pending · Not medical advice