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NCT04251065 · OUTCOME

Progression-Free Survival (PFS)

Daratumumab Plus Gemcitabine, Dexamethasone, Cisplatin in pt R/R CD38+ PTCL-NOS, AITL and TFH · Source last updated 2025-03-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percent probability at 3 months
Interval / dispersion
95% Confidence Interval
Time frame
The endpoint will be assessed from the start date of therapy up to 3 months.

What was measured

The length of time during and after the treatment that patients live with the disease, but it does not get worse. Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause. Responding patients, according to the Lugano classification response Criteria, and patients who are lost to follow-up will be censored at their last assessment date.

Groups in this outcome

One Arm

Daratumumab in combination with Gemcitabine, Dexamethasone and Cisplatin (D-GDP) in patients with relapsed/refractory CD38 positive peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of TFH cell origin.

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

Analysis denominator · Participants

GroupSource count
One Arm8

Reported measurements

Source class 1
Values in Percent probability at 3 months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
One Arm50.0Not reported15.277.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.2
        upper Limit
        77.5
        value
        50.0
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
The length of time during and after the treatment that patients live with the disease, but it does not get worse. Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause. Responding patients, according to the Lugano classification response Criteria, and patients who are lost to follow-up will be censored at their last assessment date.
dispersion Type
95% Confidence Interval
groups
  1. description
    Daratumumab in combination with Gemcitabine, Dexamethasone and Cisplatin (D-GDP) in patients with relapsed/refractory CD38 positive peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of TFH cell origin.
    id
    OG000
    title
    One Arm
param Type
NUMBER
reporting Status
POSTED
time Frame
The endpoint will be assessed from the start date of therapy up to 3 months.
title
Progression-Free Survival (PFS)
type
SECONDARY
unit Of Measure
Percent probability at 3 months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice