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NCT03595657 · OUTCOME

Duration of Response (DoR) Assessed by IRRC

A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL) · Source last updated 2024-06-18

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
From enrollment to end of follow-up, a median of 29 months

What was measured

DoR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Analysis population: Two patients were excluded from analysis: one patient was not confirmed as ENKTL by central pathology, and the other patient was identified as having no measurable or evaluable disease at baseline by IRRC.

Groups in this outcome

R/R ENKTL

Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)

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

Analysis denominator · Participants

GroupSource count
R/R ENKTL78

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
R/R ENKTL35.2Not reported25.3NAUpper limit not reached at time of data cut-off due to insufficient number of participants with an event.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
        group Id
        OG000
        lower Limit
        25.3
        upper Limit
        NA
        value
        35.2
denoms
  1. counts
    1. group Id
      OG000
      value
      78
    units
    Participants
description
DoR assessed by the independent radiological review committee (IRRC) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
    id
    OG000
    title
    R/R ENKTL
param Type
MEDIAN
population Description
Two patients were excluded from analysis: one patient was not confirmed as ENKTL by central pathology, and the other patient was identified as having no measurable or evaluable disease at baseline by IRRC.
reporting Status
POSTED
time Frame
From enrollment to end of follow-up, a median of 29 months
title
Duration of Response (DoR) Assessed by IRRC
type
SECONDARY
unit Of Measure
months

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

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