Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04251065 · OUTCOME

Complete Response Rate (CRR)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
the endpoint will be assessed from the start date of therapy to the end of the first four cycles of therapy (cycles of 21 days).

What was measured

The Complete Response Rate is defined as the percentage of patient in Complete Remission (according to Lugano classification response Criteria). It will be assessed after the first 4 cycles of D-GDP chemotherapy. In case of early discontinuation, efficacy will be assessed at the End Of Treatment (EOT) visit. Patients without response assessment (due to whatever reason) will be considered as non-responders. CR: complete radiological response, no extralymphatic sites, no new lesions, organ enlargement regress to normal and normal morphology of bone marrow; PR: \>=50% decrease of sum of the product of perpendicular diameter of up to 6 dominant, measurable nodes and and extranodal sites.

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

CRR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
One Arm0Not reportedNot reportedNot reportedNot reported

Less than CRR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
One Arm8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      title
      CRR
    2. measurements
      1. group Id
        OG000
        value
        8
      title
      Less than CRR
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
The Complete Response Rate is defined as the percentage of patient in Complete Remission (according to Lugano classification response Criteria). It will be assessed after the first 4 cycles of D-GDP chemotherapy. In case of early discontinuation, efficacy will be assessed at the End Of Treatment (EOT) visit. Patients without response assessment (due to whatever reason) will be considered as non-responders. CR: complete radiological response, no extralymphatic sites, no new lesions, organ enlargement regress to normal and normal morphology of bone marrow; PR: \>=50% decrease of sum of the product of perpendicular diameter of up to 6 dominant, measurable nodes and and extranodal sites.
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
the endpoint will be assessed from the start date of therapy to the end of the first four cycles of therapy (cycles of 21 days).
title
Complete Response Rate (CRR)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice