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NCT03386513 · OUTCOME

CCR Rate As Assessed by Investigator in All R/R BPDCN Participants With Post-Treatment Consolidative SCT

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

CCR rate was defined as percentage of participants with CR and CRc. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.

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' = all R/R BPDCN participants with post-treatment consolidative SCT. Per protocol, this endpoint evaluated only all R/R BPDCN participants with post-treatment consolidative SCT, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.

Groups in this outcome

All R/R BPDCN Participants With Post-Treatment Consolidative SCT - 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
All R/R BPDCN Participants With Post-Treatment Consolidative SCT - Schedule A: IMGN632 0.045 mg/kg6

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All R/R BPDCN Participants With Post-Treatment Consolidative SCT - Schedule A: IMGN632 0.045 mg/kg33.3Not reported4.3377.72Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.33
        upper Limit
        77.72
        value
        33.3
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
CCR rate was defined as percentage of participants with CR and CRc. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
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
    All R/R BPDCN Participants With Post-Treatment Consolidative SCT - Schedule A: IMGN632 0.045 mg/kg
param Type
NUMBER
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' = all R/R BPDCN participants with post-treatment consolidative SCT. Per protocol, this endpoint evaluated only all R/R BPDCN participants with post-treatment consolidative SCT, all of whom were in arm Schedule A: IMGN632 0.045 mg/kg.
reporting Status
POSTED
time Frame
Up to approximately 81 months
title
CCR Rate As Assessed by Investigator in All R/R BPDCN Participants With Post-Treatment Consolidative SCT
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