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NCT02348216 · OUTCOME

Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent 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: 4.1 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 CVVHD, and Grade 5: Death. Neurologic toxicities were graded by 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 6

Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells 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 corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).

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 640

Reported measurements

Worst Grade 1 CRS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 635Not reportedNot reportedNot reportedNot reported
Worst Grade 2 CRS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 645Not reportedNot reportedNot reportedNot reported
Worst Grade 3 CRS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Worst Grade 4 CRS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Worst Grade 5 CRS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 60Not reportedNot reportedNot reportedNot reported
Worst Grade ≥ 3 CRS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 60Not 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 623Not 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 618Not 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 68Not 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 65Not 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 65Not 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 618Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        35
    title
    Worst Grade 1 CRS
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        45
    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
        0
    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
        0
    title
    Worst Grade ≥ 3 CRS
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        23
    title
    Worst Grade 1 Neurologic Toxicities
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Worst Grade 2 Neurologic Toxicities
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Worst Grade 3 Neurologic Toxicities
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Worst Grade 4 Neurologic Toxicities
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Worst Grade 5 Neurologic Toxicities
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Worst Grade ≥ 3 Neurologic Toxicities
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    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 CVVHD, and Grade 5: Death. Neurologic toxicities were graded by 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 r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells 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 corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
    id
    OG000
    title
    Phase 2 (Safety Management Study): Cohort 6
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: 4.1 years)
title
Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent 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