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NCT04251065 · OUTCOME

Percentage of CD38 Expression in Correlation With the Response to the Treatment

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 from the start date of therapy to the end of the first four cycle of therapy (cycles of 21 days) and at each restaging through study completion, up to 26 months.

What was measured

This endpoint will evaluate the correlation between intensity of CD38 expression (percentage of expression) and response to the treatment. The extent of CD38 expression evaluated by the central designed laboratory of FIL (Fondazione Italiana Linfomi) will be performed on fresh sections cut from the paraffin block (or on unstained sections), and the percentage of positive tumor cells will be scored according to Bossard C. et al as follows: 4: \>75%; 3: 50-75%; 2: 25-49%; 1: 5-24%; 0: \<5%. The percentage of CD38 expression will be correlated with response measured according to the Lugano 2014 criteria

Analysis population: No data displayed because Outcome Measure has zero total participants analyzed. 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
This endpoint will evaluate the correlation between intensity of CD38 expression (percentage of expression) and response to the treatment. The extent of CD38 expression evaluated by the central designed laboratory of FIL (Fondazione Italiana Linfomi) will be performed on fresh sections cut from the paraffin block (or on unstained sections), and the percentage of positive tumor cells will be scored according to Bossard C. et al as follows: 4: \>75%; 3: 50-75%; 2: 25-49%; 1: 5-24%; 0: \<5%. The percentage of CD38 expression will be correlated with response measured according to the Lugano 2014 criteria
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
No data displayed because Outcome Measure has zero total participants analyzed. So, data were not collected.
reporting Status
POSTED
time Frame
The endpoint will be assessed from the start date of therapy to the end of the first four cycle of therapy (cycles of 21 days) and at each restaging through study completion, up to 26 months.
title
Percentage of CD38 Expression in Correlation With the Response to the Treatment
type
OTHER_PRE_SPECIFIED

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

Preserved source evidence · Not medical advice