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NCT02435849 · OUTCOME

Develop a Score Utilizing Clinical and Biomarker Data and Assess Its Ability for Early Prediction of Cytokine Release Syndrome (CRS)

Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients · Source last updated 2024-02-13

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
3 months

What was measured

Derivation of a score to predict cytokine release syndrome. Considering the complexity and challenges of building a scoring system based on limited data from the trial, this analysis was not performed.

Analysis population: This objective was not associated with any data collection from participants. The original plan was to mathematically derive a score from other endpoints measures (e.g., a score combing age, value of CRP, Ferritin, Interferon gamma, etc.). Those potential biomarkers were used to derive the scores that are already reported in other tables. None of the biomarkers analyzed proved to be prognostic for the onset or severity of CRS, hence finally no score was derived and no data for this objective.

Groups in this outcome

Main Cohort: Single Dose of CTL019

Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).

Cohort 1: Single Dose of CTL019

Pediatric B-ALL patients who are very high risk at first relapse.

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

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL0190
Cohort 1: Single Dose of CTL0190

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
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Derivation of a score to predict cytokine release syndrome. Considering the complexity and challenges of building a scoring system based on limited data from the trial, this analysis was not performed.
groups
  1. description
    Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).
    id
    OG000
    title
    Main Cohort: Single Dose of CTL019
  2. description
    Pediatric B-ALL patients who are very high risk at first relapse.
    id
    OG001
    title
    Cohort 1: Single Dose of CTL019
population Description
This objective was not associated with any data collection from participants. The original plan was to mathematically derive a score from other endpoints measures (e.g., a score combing age, value of CRP, Ferritin, Interferon gamma, etc.). Those potential biomarkers were used to derive the scores that are already reported in other tables. None of the biomarkers analyzed proved to be prognostic for the onset or severity of CRS, hence finally no score was derived and no data for this objective.
reporting Status
POSTED
time Frame
3 months
title
Develop a Score Utilizing Clinical and Biomarker Data and Assess Its Ability for Early Prediction of Cytokine Release Syndrome (CRS)
type
SECONDARY

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice