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NCT04251065 · OUTCOME

Role of Daratumumab Maintenance CR vs PR

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
The endpoint will be assessed at each restaging through study completion, up to 26 months.

What was measured

The evaluation of the rate of conversion in Complete Remission with daratumumab maintenance therapy for patients in Partial Remission after the induction. With this endpoint it will be measured the number of responses that will be converted from Partial Remission (PR) to Complete Remission (CR) in those patients that after induction therapy continued the treatment with the maintenance therapy.

Analysis population: Due the early interruption of the trial, this end point was not evaluated. So, data were not collected.

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 Arm0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
The evaluation of the rate of conversion in Complete Remission with daratumumab maintenance therapy for patients in Partial Remission after the induction. With this endpoint it will be measured the number of responses that will be converted from Partial Remission (PR) to Complete Remission (CR) in those patients that after induction therapy continued the treatment with the maintenance therapy.
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
population Description
Due the early interruption of the trial, this end point was not evaluated. So, data were not collected.
reporting Status
POSTED
time Frame
The endpoint will be assessed at each restaging through study completion, up to 26 months.
title
Role of Daratumumab Maintenance CR vs PR
type
OTHER_PRE_SPECIFIED

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

Preserved source evidence · Not medical advice