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NCT03595657 · BASELINE

Baseline characteristics

A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL) · Source last updated 2024-06-18

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

denoms
  1. counts
    1. group Id
      BG000
      value
      80
    units
    Participants
groups
  1. description
    Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
    id
    BG000
    title
    R/R ENKTL
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          66
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          14
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.68
          value
          48.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          51
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          80
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          80
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          80
      title
      China
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          59
      title
      1
    description
    0-Fully active, able to carry on all pre-disease performance without restriction. 1-Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2-Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours. 3-Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. 4-Completely disabled; cannot carry on any selfcare; totally confined to bed or chair. 5-Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group Performance Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          54
      title
      Stage IV
    description
    Based on Ann Arbor classification: Stage I - Involvement: 1 node or a group of adjacent nodes. Extranodal Status: Single extranodal lesion without nodal involvement. Stage II - Involvement: 2 or more nodal groups on the same side of the diaphragm. Extranodal Status: Stage I/II by nodal extent with limited contiguous extranodal involvement. Stage III - Involvement: Nodes on both sides of the diaphragm; nodes above the diaphragm with spleen involvement. Extranodal Status: N/A. Stage IV - Involvement: Additional noncontiguous extralymphatic involvement. Extranodal Status: N/A.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stage of Extranodal Natural Killer/ T-cell Lymphoma at screening
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          44
      title
      Positive
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          36
      title
      Negative
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Epstein-Barr Virus (EBV) DNA at Screening
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Positive
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          73
      title
      Negative
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Missing
    description
    Assessments were performed at baseline to determine whether a patient had bone marrow involvement by the disease. "Positive" indicates the presence of involvement; "negative" indicates absence of involvement; "missing" indicates results not applicable.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline Bone Marrow Assessment Result
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          79
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Central Pathology Confirmed ENKTL
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          43
      title
      Relapsed
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          37
      title
      Refractory
    description
    Participants in this study must have relapsed or refractory ENKTL failing asparaginase-based chemotherapy or chemoradiotherapy. "Relapse" indicates disease progression after response to the last treatment; "refractory" indicates no response to the last treatment.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Patient Status
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      80
    units
    Participants
groups
  1. description
    Participants received sugemalimab (CS1001) 1200 mg intravenously every 3 weeks (Q3W)
    id
    BG000
    title
    R/R ENKTL
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          66
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          14
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.68
          value
          48.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          51
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          80
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          80
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          80
      title
      China
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          59
      title
      1
    description
    0-Fully active, able to carry on all pre-disease performance without restriction. 1-Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2-Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours. 3-Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. 4-Completely disabled; cannot carry on any selfcare; totally confined to bed or chair. 5-Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group Performance Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          54
      title
      Stage IV
    description
    Based on Ann Arbor classification: Stage I - Involvement: 1 node or a group of adjacent nodes. Extranodal Status: Single extranodal lesion without nodal involvement. Stage II - Involvement: 2 or more nodal groups on the same side of the diaphragm. Extranodal Status: Stage I/II by nodal extent with limited contiguous extranodal involvement. Stage III - Involvement: Nodes on both sides of the diaphragm; nodes above the diaphragm with spleen involvement. Extranodal Status: N/A. Stage IV - Involvement: Additional noncontiguous extralymphatic involvement. Extranodal Status: N/A.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stage of Extranodal Natural Killer/ T-cell Lymphoma at screening
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          44
      title
      Positive
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          36
      title
      Negative
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Epstein-Barr Virus (EBV) DNA at Screening
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Positive
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          73
      title
      Negative
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Missing
    description
    Assessments were performed at baseline to determine whether a patient had bone marrow involvement by the disease. "Positive" indicates the presence of involvement; "negative" indicates absence of involvement; "missing" indicates results not applicable.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline Bone Marrow Assessment Result
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          79
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Central Pathology Confirmed ENKTL
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          43
      title
      Relapsed
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          37
      title
      Refractory
    description
    Participants in this study must have relapsed or refractory ENKTL failing asparaginase-based chemotherapy or chemoradiotherapy. "Relapse" indicates disease progression after response to the last treatment; "refractory" indicates no response to the last treatment.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Patient Status
    unit Of Measure
    Participants

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

Preserved source evidence · Independent clinical review pending · Not medical advice