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NCT03483103 · OUTCOME

Change From Baseline of Chemistry Laboratory Results: Bilirubin, Creatinine, Direct Bilirubin, Urate

Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006) · Source last updated 2023-12-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
umol/L
Interval / dispersion
Standard Deviation
Time frame
Baseline and Day 29

What was measured

Change from baseline in Chemistry laboratory analysis. Includes Bilirubin, Creatinine, Direct Bilirubin, and Urate. Baseline is the last observation collected prior to or on the date of product infusion.

Analysis population: All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests

Groups in this outcome

Lisocabtagene Maraleucel (JCAR017)

Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells) administered intravenously (IV) 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
Lisocabtagene Maraleucel (JCAR017)59

Reported measurements

Bilirubin

Analysis denominator · Participants

GroupSource count
Lisocabtagene Maraleucel (JCAR017)59
Values in umol/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lisocabtagene Maraleucel (JCAR017)-0.17416.36075Not reportedNot reportedNot reported
Creatinine

Analysis denominator · Participants

GroupSource count
Lisocabtagene Maraleucel (JCAR017)59
Values in umol/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lisocabtagene Maraleucel (JCAR017)5.873421.32985Not reportedNot reportedNot reported
Direct Bilirubin

Analysis denominator · Participants

GroupSource count
Lisocabtagene Maraleucel (JCAR017)55
Values in umol/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lisocabtagene Maraleucel (JCAR017)0.03062.35650Not reportedNot reportedNot reported
Urate

Analysis denominator · Participants

GroupSource count
Lisocabtagene Maraleucel (JCAR017)56
Values in umol/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lisocabtagene Maraleucel (JCAR017)5.789793.90174Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.36075
        value
        -0.1741
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    Bilirubin
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.32985
        value
        5.8734
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    Creatinine
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.35650
        value
        0.0306
    denoms
    1. counts
      1. group Id
        OG000
        value
        55
      units
      Participants
    title
    Direct Bilirubin
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        93.90174
        value
        5.7897
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      units
      Participants
    title
    Urate
denoms
  1. counts
    1. group Id
      OG000
      value
      59
    units
    Participants
description
Change from baseline in Chemistry laboratory analysis. Includes Bilirubin, Creatinine, Direct Bilirubin, and Urate. Baseline is the last observation collected prior to or on the date of product infusion.
dispersion Type
Standard Deviation
groups
  1. description
    Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
    id
    OG000
    title
    Lisocabtagene Maraleucel (JCAR017)
param Type
MEAN
population Description
All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests
reporting Status
POSTED
time Frame
Baseline and Day 29
title
Change From Baseline of Chemistry Laboratory Results: Bilirubin, Creatinine, Direct Bilirubin, Urate
type
SECONDARY
unit Of Measure
umol/L

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

Preserved source evidence · Not medical advice