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NCT03907488 · FLOW

Participant flow

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.

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
    FG000
    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
    FG001
    title
    Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        20
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        13
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        9
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        8
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        8
      type
      not protocol specified
    6. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        15
      type
      Ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        496
      2. group Id
        FG001
        num Subjects
        498
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        450
      2. group Id
        FG001
        num Subjects
        425
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        73
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
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
    FG000
    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
    FG001
    title
    Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        20
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        13
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        9
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        8
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        8
      type
      not protocol specified
    6. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        15
      type
      Ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        496
      2. group Id
        FG001
        num Subjects
        498
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        450
      2. group Id
        FG001
        num Subjects
        425
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        73
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice