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NCT03386513 · OUTCOME

Duration of Overall Response As Assessed by Investigator in Total R/R 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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 81 months

What was measured

Duration of overall response (CR, CRc, CRh, CRi, and PR) was defined as time from first response to time of relapse or death from any cause, whichever came first. CR, CRc, and CRh, CRi, and PR as defined in Outcome Measure 21 above.

Analysis population: mITT Population included all participants who were eligible based on the screening criteria and who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = Total R/R BPDCN participants with overall response. Per protocol, this endpoint evaluated only total R/R BPDCN participants with overall response, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.

Groups in this outcome

Total R/R 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
Total R/R BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg10

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Total R/R BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg4.14Not reported1.807NAData could not be calculated due to insufficient number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Data could not be calculated due to insufficient number of events.
        group Id
        OG000
        lower Limit
        1.807
        upper Limit
        NA
        value
        4.14
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
Duration of overall response (CR, CRc, CRh, CRi, and PR) was defined as time from first response to time of relapse or death from any cause, whichever came first. CR, CRc, and CRh, CRi, and PR as defined in Outcome Measure 21 above.
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
    Total R/R BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg
param Type
MEDIAN
population Description
mITT Population included all participants who were eligible based on the screening criteria and who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = Total R/R BPDCN participants with overall response. Per protocol, this endpoint evaluated only total R/R BPDCN participants with overall response, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.
reporting Status
POSTED
time Frame
Up to approximately 81 months
title
Duration of Overall Response As Assessed by Investigator in Total R/R BPDCN Participants
type
SECONDARY
unit Of Measure
months

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

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