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NCT03595657 · OUTCOME

Objective Response Rate (ORR) Assessed by Investigators

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From enrollment to end of follow-up, a median of 29 months

What was measured

ORR assessed by investigators according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Analysis population: One patient was excluded from the efficacy analysis set because the patient was not confirmed as ENKTL by central pathology.

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 ENKTL79

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
R/R ENKTL45.6Not reported34.357.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        34.3
        upper Limit
        57.2
        value
        45.6
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    units
    Participants
description
ORR assessed by investigators 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
NUMBER
population Description
One patient was excluded from the efficacy analysis set because the patient was not confirmed as ENKTL by central pathology.
reporting Status
POSTED
time Frame
From enrollment to end of follow-up, a median of 29 months
title
Objective Response Rate (ORR) Assessed by Investigators
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