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NCT02348216 · OUTCOME

Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades

Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma · Source last updated 2024-06-04

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
First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 6.8 years)

What was measured

TEAE was defined as any AE with onset on or after the start of treatment. CRS events were graded by Lee et al 2014. Grade 1 : No life threatening symptoms and require symptomatic treatment only; Grade 2: Symptoms require and respond to moderate intervention; Grade 3: Symptoms require and respond to aggressive intervention; Grade 4: Life-threatening symptoms and requirements for ventilator support or continuous venovenous hemodialysis (CVVHD), and Grade 5: Death. Neurologic toxicities were graded by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: Mild, asymptomatic or mild symptoms and intervention not indicated; Grade 2: Moderate and minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening and urgent intervention indicated; Grade 5: Death related to AE.

Analysis population: The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel.

Groups in this outcome

Phase 2 (Safety Management Study): Cohort 3

Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).

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

Analysis denominator · Participants

GroupSource count
Phase 2 (Safety Management Study): Cohort 338

Reported measurements

Worst Grade 1 CRS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 334Not reportedNot reportedNot reportedNot reported
Worst Grade 2 CRS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 355Not reportedNot reportedNot reportedNot reported
Worst Grade 3 CRS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Worst Grade 4 CRS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 33Not reportedNot reportedNot reportedNot reported
Worst Grade 5 CRS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 30Not reportedNot reportedNot reportedNot reported
Worst Grade ≥ 3 CRS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 33Not reportedNot reportedNot reportedNot reported
Worst Grade 1 Neurologic Toxicities
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 324Not reportedNot reportedNot reportedNot reported
Worst Grade 2 Neurologic Toxicities
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 321Not reportedNot reportedNot reportedNot reported
Worst Grade 3 Neurologic Toxicities
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 337Not reportedNot reportedNot reportedNot reported
Worst Grade 4 Neurologic Toxicities
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 33Not reportedNot reportedNot reportedNot reported
Worst Grade 5 Neurologic Toxicities
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 33Not reportedNot reportedNot reportedNot reported
Worst Grade ≥ 3 Neurologic Toxicities
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 342Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        34
    title
    Worst Grade 1 CRS
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        55
    title
    Worst Grade 2 CRS
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Worst Grade 3 CRS
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Worst Grade 4 CRS
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Worst Grade 5 CRS
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Worst Grade ≥ 3 CRS
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        24
    title
    Worst Grade 1 Neurologic Toxicities
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        21
    title
    Worst Grade 2 Neurologic Toxicities
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        37
    title
    Worst Grade 3 Neurologic Toxicities
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Worst Grade 4 Neurologic Toxicities
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Worst Grade 5 Neurologic Toxicities
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        42
    title
    Worst Grade ≥ 3 Neurologic Toxicities
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    units
    Participants
description
TEAE was defined as any AE with onset on or after the start of treatment. CRS events were graded by Lee et al 2014. Grade 1 : No life threatening symptoms and require symptomatic treatment only; Grade 2: Symptoms require and respond to moderate intervention; Grade 3: Symptoms require and respond to aggressive intervention; Grade 4: Life-threatening symptoms and requirements for ventilator support or continuous venovenous hemodialysis (CVVHD), and Grade 5: Death. Neurologic toxicities were graded by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: Mild, asymptomatic or mild symptoms and intervention not indicated; Grade 2: Moderate and minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening and urgent intervention indicated; Grade 5: Death related to AE.
groups
  1. description
    Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
    id
    OG000
    title
    Phase 2 (Safety Management Study): Cohort 3
param Type
NUMBER
population Description
The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel.
reporting Status
POSTED
time Frame
First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 6.8 years)
title
Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice