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NCT01583686 · OUTCOME

Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)

CAR T Cell Receptor Immunotherapy Targeting Mesothelin for Patients With Metastatic Cancer · Source last updated 2019-10-14

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.

What was measured

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Groups in this outcome

Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2

1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin

Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2

1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin

Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2

1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin

Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2

1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin

Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2

1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin

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

Analysis denominator · Participants

GroupSource count
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-23
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-23
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-23
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-23
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-23

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-23Not reportedNot reportedNot reportedNot reported
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-23Not reportedNot reportedNot reportedNot reported
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-23Not reportedNot reportedNot reportedNot reported
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-23Not reportedNot reportedNot reportedNot reported
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-23Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      3
    units
    Participants
description
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
groups
  1. description
    1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin
    id
    OG000
    title
    Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2
  2. description
    1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin
    id
    OG001
    title
    Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2
  3. description
    1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin
    id
    OG002
    title
    Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2
  4. description
    1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin
    id
    OG003
    title
    Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2
  5. description
    1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin
    id
    OG004
    title
    Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
title
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice