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NCT03484702 · OUTCOME

Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohorts 1, 2, 3, 4, and 5

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 cohorts 1, 2, 3, 4, and 5 only.

Groups in this outcome

Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy

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).

Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy

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).

Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2

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).

Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma

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).

Cohort 5: Primary Central Nervous System Lymphoma

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 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy35
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy24
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma4

Reported measurements

Albumin (g/L) - Day 29

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy35
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy24
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy0Not reportedNot reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy0Not reportedNot reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 20Not reportedNot reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0Not reportedNot reportedNot reportedNot reported
Cohort 5: Primary Central Nervous System Lymphoma0Not reportedNot reportedNot reportedNot reported
Phosphate (mmol/L) - Day 29

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy35
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy24
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy0Not reportedNot reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy1Not reportedNot reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 20Not reportedNot reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0Not reportedNot reportedNot reportedNot reported
Cohort 5: Primary Central Nervous System Lymphoma0Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase (U/L) - Day 29

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy35
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy24
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy2Not reportedNot reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy1Not reportedNot reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 20Not reportedNot reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0Not reportedNot reportedNot reportedNot reported
Cohort 5: Primary Central Nervous System Lymphoma1Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase (U/L) - Day 29

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy35
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy24
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy10Not reportedNot reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy3Not reportedNot reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 21Not reportedNot reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0Not reportedNot reportedNot reportedNot reported
Cohort 5: Primary Central Nervous System Lymphoma2Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase (U/L) - Day 29

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy35
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy23
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy6Not reportedNot reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy3Not reportedNot reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 21Not reportedNot reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0Not reportedNot reportedNot reportedNot reported
Cohort 5: Primary Central Nervous System Lymphoma3Not reportedNot reportedNot reportedNot reported
Bilirubin (umol/L) - Day 29

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy34
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy23
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy2Not reportedNot reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy0Not reportedNot reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 20Not reportedNot reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0Not reportedNot reportedNot reportedNot reported
Cohort 5: Primary Central Nervous System Lymphoma0Not reportedNot reportedNot reportedNot reported
Creatinine (umol/L) - Day 29

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy35
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy24
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy23Not reportedNot reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy20Not reportedNot reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 26Not reportedNot reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1Not reportedNot reportedNot reportedNot reported
Cohort 5: Primary Central Nervous System Lymphoma3Not reportedNot reportedNot reportedNot reported
Triglycerides (mmol/L) - Day 29

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy35
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy24
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy10Not reportedNot reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy6Not reportedNot reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 22Not reportedNot reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0Not reportedNot reportedNot reportedNot reported
Cohort 5: Primary Central Nervous System Lymphoma2Not reportedNot reportedNot reportedNot reported
Urate (umol/L) - Day 29

Analysis denominator · Participants

GroupSource count
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy35
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy24
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 210
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma1
Cohort 5: Primary Central Nervous System Lymphoma4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy1Not reportedNot reportedNot reportedNot reported
Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy0Not reportedNot reportedNot reportedNot reported
Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 20Not reportedNot reportedNot reportedNot reported
Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma0Not reportedNot reportedNot reportedNot reported
Cohort 5: Primary Central Nervous System Lymphoma0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        4
      units
      Participants
    title
    Albumin (g/L) - Day 29
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        4
      units
      Participants
    title
    Phosphate (mmol/L) - Day 29
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        4
      units
      Participants
    title
    Alkaline Phosphatase (U/L) - Day 29
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        4
      units
      Participants
    title
    Alanine Aminotransferase (U/L) - Day 29
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        23
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        4
      units
      Participants
    title
    Aspartate Aminotransferase (U/L) - Day 29
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        23
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        4
      units
      Participants
    title
    Bilirubin (umol/L) - Day 29
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        4
      units
      Participants
    title
    Creatinine (umol/L) - Day 29
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        4
      units
      Participants
    title
    Triglycerides (mmol/L) - Day 29
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        4
      units
      Participants
    title
    Urate (umol/L) - Day 29
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    2. group Id
      OG001
      value
      24
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      4
    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 1: Diffuse B-cell Lymphoma Who Failed ≥ 2 Lines of Therapy
  2. 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
    OG001
    title
    Cohort 2: Transplant Ineligible Diffuse B-cell Lymphoma Who Failed First Line Therapy
  3. 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
    OG002
    title
    Cohort 3: Japan Specific - Meeting Eligibility Criteria for Cohort 1 or 2
  4. 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
    OG003
    title
    Cohort 4: Newly Diagnosed High-Grade B-cell Lymphoma
  5. 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
    OG004
    title
    Cohort 5: Primary Central Nervous System Lymphoma
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 cohorts 1, 2, 3, 4, and 5 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 - Cohorts 1, 2, 3, 4, and 5
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice