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NCT03907488 · BASELINE

Baseline characteristics

Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma · Source last updated 2026-08-04

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
      487
    2. group Id
      BG001
      value
      483
    3. group Id
      BG002
      value
      970
    units
    Participants
groups
  1. description
    Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study. Biospecimen Collection: Undergo peripheral blood collection Computed Tomography: Undergo PET/CT or CT scan Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Filgrastim: Given SC or IV Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV Pegfilgrastim: Given SC Positron Emission Tomography: Undergo PET/CT scan Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Radiation Therapy: Receive radiation therapy Vinblastine Sulfate: Given IV
    id
    BG000
    title
    Arm I (Chemotherapy, Nivolumab, Radiation)
  2. description
    Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study. Biospecimen Collection: Undergo peripheral blood collection Brentuximab Vedotin: Given IV Computed Tomography: Undergo PET/CT or CT scan Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Filgrastim: Given SC or IV Magnetic Resonance Imaging: Undergo MRI Pegfilgrastim: Given SC Positron Emission Tomography: Undergo PET/CT scan Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Radiation Therapy: Receive radiation therapy Vinblastine Sulfate: Given IV
    id
    BG001
    title
    Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          12.0
          upper Limit
          83.7
          value
          27.6
        2. group Id
          BG001
          lower Limit
          12.0
          upper Limit
          81.7
          value
          26.8
        3. group Id
          BG002
          lower Limit
          12.0
          upper Limit
          83.7
          value
          27
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          236
        title
        12-17
      2. measurements
        1. group Id
          BG000
          value
          321
        2. group Id
          BG001
          value
          318
        3. group Id
          BG002
          value
          639
        title
        18-60
      3. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          95
        title
        >60
      title
      Age, Stratified
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          216
        2. group Id
          BG001
          value
          210
        3. group Id
          BG002
          value
          426
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          271
        2. group Id
          BG001
          value
          273
        3. group Id
          BG002
          value
          544
        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
          372
        2. group Id
          BG001
          value
          361
        3. group Id
          BG002
          value
          733
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          114
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          28
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          95
      title
      Other or unknown
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          124
      title
      Hispanic
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Modified intent to treat group, in participants deemed ineligible are excluded.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      487
    2. group Id
      BG001
      value
      483
    3. group Id
      BG002
      value
      970
    units
    Participants
groups
  1. description
    Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and nivolumab IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study. Biospecimen Collection: Undergo peripheral blood collection Computed Tomography: Undergo PET/CT or CT scan Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Filgrastim: Given SC or IV Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV Pegfilgrastim: Given SC Positron Emission Tomography: Undergo PET/CT scan Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Radiation Therapy: Receive radiation therapy Vinblastine Sulfate: Given IV
    id
    BG000
    title
    Arm I (Chemotherapy, Nivolumab, Radiation)
  2. description
    Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, dacarbazine IV, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Patients may receive pegfilgrastim SC on days 2 and 16, or filgrastim SC or IV on days 6-10 and 21-25. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of cycle 6, patients may receive radiation therapy 5 days per week for approximately 4 weeks at the discretion of the treating physician. Patients also undergo peripheral blood specimen collection and CT, PET/CT and MRI on study. Biospecimen Collection: Undergo peripheral blood collection Brentuximab Vedotin: Given IV Computed Tomography: Undergo PET/CT or CT scan Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Filgrastim: Given SC or IV Magnetic Resonance Imaging: Undergo MRI Pegfilgrastim: Given SC Positron Emission Tomography: Undergo PET/CT scan Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Radiation Therapy: Receive radiation therapy Vinblastine Sulfate: Given IV
    id
    BG001
    title
    Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          12.0
          upper Limit
          83.7
          value
          27.6
        2. group Id
          BG001
          lower Limit
          12.0
          upper Limit
          81.7
          value
          26.8
        3. group Id
          BG002
          lower Limit
          12.0
          upper Limit
          83.7
          value
          27
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          236
        title
        12-17
      2. measurements
        1. group Id
          BG000
          value
          321
        2. group Id
          BG001
          value
          318
        3. group Id
          BG002
          value
          639
        title
        18-60
      3. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          95
        title
        >60
      title
      Age, Stratified
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          216
        2. group Id
          BG001
          value
          210
        3. group Id
          BG002
          value
          426
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          271
        2. group Id
          BG001
          value
          273
        3. group Id
          BG002
          value
          544
        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
          372
        2. group Id
          BG001
          value
          361
        3. group Id
          BG002
          value
          733
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          114
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          28
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          95
      title
      Other or unknown
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          124
      title
      Hispanic
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Modified intent to treat group, in participants deemed ineligible are excluded.

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

Preserved source evidence · Not medical advice