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NCT02348216 · OUTCOME

Phase 2 Safety Management Study (Cohort 5): 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: 4.4 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 5

Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), 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 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 BID starting on D0).D=Day.

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 550

Reported measurements

Worst Grade 1 CRS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 538Not reportedNot reportedNot reportedNot reported
Worst Grade 2 CRS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 546Not reportedNot reportedNot reportedNot reported
Worst Grade 3 CRS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Worst Grade 4 CRS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 52Not reportedNot reportedNot reportedNot reported
Worst Grade 5 CRS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 50Not reportedNot reportedNot reportedNot reported
Worst Grade ≥ 3 CRS
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 (Safety Management Study): Cohort 52Not 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 526Not 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 518Not 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 510Not 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 52Not 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 50Not 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 512Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        38
    title
    Worst Grade 1 CRS
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        46
    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
        2
    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
        2
    title
    Worst Grade ≥ 3 CRS
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        26
    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
        10
    title
    Worst Grade 3 Neurologic Toxicities
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Worst Grade 4 Neurologic Toxicities
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Worst Grade 5 Neurologic Toxicities
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    Worst Grade ≥ 3 Neurologic Toxicities
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    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 received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), 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 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 BID starting on D0).D=Day.
    id
    OG000
    title
    Phase 2 (Safety Management Study): Cohort 5
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: 4.4 years)
title
Phase 2 Safety Management Study (Cohort 5): 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