Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03484702 · OUTCOME

Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7

Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma · Source last updated 2024-12-27

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
At Baseline and Day 29 after JCAR017 infusion

What was measured

JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).

Analysis population: All participants in the JCAR017 treated set with available baseline and Day 29 serum chemistry results. Prespecified to be reported for cohort 7 only

Groups in this outcome

Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting

JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).

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

Analysis denominator · Participants

GroupSource count
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9

Reported measurements

Albumin (g/L) - Day 29

Analysis denominator · Participants

GroupSource count
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting0Not reportedNot reportedNot reportedNot reported
Phosphate (mmol/L) - Day 29

Analysis denominator · Participants

GroupSource count
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting8
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting0Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase (U/L) - Day 29

Analysis denominator · Participants

GroupSource count
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting0Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase (U/L) - Day 29

Analysis denominator · Participants

GroupSource count
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting0Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase (U/L) - Day 29

Analysis denominator · Participants

GroupSource count
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting1Not reportedNot reportedNot reportedNot reported
Bilirubin (umol/L) - Day 29

Analysis denominator · Participants

GroupSource count
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting0Not reportedNot reportedNot reportedNot reported
Creatinine (umol/L) - Day 29

Analysis denominator · Participants

GroupSource count
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting7Not reportedNot reportedNot reportedNot reported
Triglycerides (mmol/L) - Day 29

Analysis denominator · Participants

GroupSource count
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting3Not reportedNot reportedNot reportedNot reported
Urate (umol/L) - Day 29

Analysis denominator · Participants

GroupSource count
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Albumin (g/L) - Day 29
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Phosphate (mmol/L) - Day 29
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Alkaline Phosphatase (U/L) - Day 29
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Alanine Aminotransferase (U/L) - Day 29
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Aspartate Aminotransferase (U/L) - Day 29
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Bilirubin (umol/L) - Day 29
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Creatinine (umol/L) - Day 29
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Triglycerides (mmol/L) - Day 29
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Urate (umol/L) - Day 29
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    units
    Participants
description
JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).
groups
  1. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    OG000
    title
    Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants in the JCAR017 treated set with available baseline and Day 29 serum chemistry results. Prespecified to be reported for cohort 7 only
reporting Status
POSTED
time Frame
At Baseline and Day 29 after JCAR017 infusion
title
Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice