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NCT02348216 · OUTCOME

Pharmacodynamics: Peak Level of Cytokine (Ferritin) in Serum (Phase 1 and Phase 2 Cohorts 1 and 2)

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
MEDIAN
Unit
pg/mL
Interval / dispersion
Full Range
Time frame
Baseline up to Month 3

What was measured

Peak was defined as the maximum post-baseline level of the cytokine.

Analysis population: Participants in the Safety Analysis Set were analyzed.

Groups in this outcome

Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy

Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] 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 chimeric antigen receptor (CAR) transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight (BW) on Day 0.

Phase 2 (Pivotal Study): Cohort 1

Participants with refractory DLBCL 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.

Phase 2 (Pivotal Study): Cohort 2

Participants with refractory 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.

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 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy7
Phase 2 (Pivotal Study): Cohort 177
Phase 2 (Pivotal Study): Cohort 224

Reported measurements

Source class 1
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy1973400.0Not reported1201900.032984400.0Not reported
Phase 2 (Pivotal Study): Cohort 13681400.0Not reported780.025000000.0Not reported
Phase 2 (Pivotal Study): Cohort 21979360.0Not reported780.025000000.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1201900.0
        upper Limit
        32984400.0
        value
        1973400.0
      2. group Id
        OG001
        lower Limit
        780.0
        upper Limit
        25000000.0
        value
        3681400.0
      3. group Id
        OG002
        lower Limit
        780.0
        upper Limit
        25000000.0
        value
        1979360.0
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      77
    3. group Id
      OG002
      value
      24
    units
    Participants
description
Peak was defined as the maximum post-baseline level of the cytokine.
dispersion Type
Full Range
groups
  1. description
    Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\^2 intravenously \[IV\] 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 chimeric antigen receptor (CAR) transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight (BW) on Day 0.
    id
    OG000
    title
    Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy
  2. description
    Participants with refractory DLBCL 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.
    id
    OG001
    title
    Phase 2 (Pivotal Study): Cohort 1
  3. description
    Participants with refractory 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.
    id
    OG002
    title
    Phase 2 (Pivotal Study): Cohort 2
param Type
MEDIAN
population Description
Participants in the Safety Analysis Set were analyzed.
reporting Status
POSTED
time Frame
Baseline up to Month 3
title
Pharmacodynamics: Peak Level of Cytokine (Ferritin) in Serum (Phase 1 and Phase 2 Cohorts 1 and 2)
type
SECONDARY
unit Of Measure
pg/mL

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

Preserved source evidence · Not medical advice