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NCT03391466 · OUTCOME

Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher

Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma · Source last updated 2025-12-01

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
From first dose up to 61.8 months

What was measured

Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. Percentages were rounded off.

Analysis population: Participants in the Safety Analysis Set with available data were analyzed.

Groups in this outcome

Axicabtagene Ciloleucel

Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.

Standard of Care Therapy

Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen: * R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; * R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5; * R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or * R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2. Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.

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

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel170
Standard of Care Therapy168

Reported measurements

Hemoglobin (mmol/L)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel0Not reportedNot reportedNot reportedNot reported
Standard of Care Therapy0Not reportedNot reportedNot reportedNot reported
Leukocytes (10^9/L)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel0Not reportedNot reportedNot reportedNot reported
Standard of Care Therapy1Not reportedNot reportedNot reportedNot reported
Lymphocytes (10^9/L)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel0Not reportedNot reportedNot reportedNot reported
Standard of Care Therapy0Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase (U/L)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel6Not reportedNot reportedNot reportedNot reported
Standard of Care Therapy4Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase (U/L)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel1Not reportedNot reportedNot reportedNot reported
Standard of Care Therapy1Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase (U/L)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel6Not reportedNot reportedNot reportedNot reported
Standard of Care Therapy2Not reportedNot reportedNot reportedNot reported
Bilirubin (umol/L)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel2Not reportedNot reportedNot reportedNot reported
Standard of Care Therapy1Not reportedNot reportedNot reportedNot reported
Calcium (mmol/L)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel2Not reportedNot reportedNot reportedNot reported
Standard of Care Therapy1Not reportedNot reportedNot reportedNot reported
Creatinine (umol/L)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel4Not reportedNot reportedNot reportedNot reported
Standard of Care Therapy1Not reportedNot reportedNot reportedNot reported
Glucose (mmol/L)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel14Not reportedNot reportedNot reportedNot reported
Standard of Care Therapy5Not reportedNot reportedNot reportedNot reported
Magnesium (mmol/L)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel2Not reportedNot reportedNot reportedNot reported
Standard of Care Therapy0Not reportedNot reportedNot reportedNot reported
Potassium (mmol/L)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel0Not reportedNot reportedNot reportedNot reported
Standard of Care Therapy1Not reportedNot reportedNot reportedNot reported
Sodium (mmol/L)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel0Not reportedNot reportedNot reportedNot reported
Standard of Care Therapy0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Hemoglobin (mmol/L)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Leukocytes (10^9/L)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Lymphocytes (10^9/L)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        4
    title
    Alanine Aminotransferase (U/L)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Alkaline Phosphatase (U/L)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        2
    title
    Aspartate Aminotransferase (U/L)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    Bilirubin (umol/L)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    Calcium (mmol/L)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        1
    title
    Creatinine (umol/L)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        5
    title
    Glucose (mmol/L)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Magnesium (mmol/L)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Potassium (mmol/L)
denoms
  1. counts
    1. group Id
      OG000
      value
      170
    2. group Id
      OG001
      value
      168
    units
    Participants
description
Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. Percentages were rounded off.
groups
  1. description
    Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
    id
    OG000
    title
    Axicabtagene Ciloleucel
  2. description
    Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen: * R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; * R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5; * R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or * R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2. Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
    id
    OG001
    title
    Standard of Care Therapy
param Type
NUMBER
population Description
Participants in the Safety Analysis Set with available data were analyzed.
reporting Status
POSTED
time Frame
From first dose up to 61.8 months
title
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice