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NCT03907488 · OUTCOME

Event-free Survival (EFS)

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From date of registration to date of first occurrence of EFS event, assessed at 2 years

What was measured

Will be reported as count of participants who have experienced an EFS event or death at two years. EFS Events are defined as: * Disease progression/relapse * Administration of non-protocol specified systemic anti-lymphoma therapy (i.e. salvage therapy) at any time after initiation of protocol therapy. * Administration of any non-protocol specified radiation therapy at any time afterinitiation of protocol therapy Will be estimated using Kaplan-Meier method and compared between treatment arms using cox regression model.

Analysis population: All the patients who underwent randomization except for those who were deemed to be ineligible by pathology review or owing to violation of the eligibility criteria.

Groups in this outcome

Arm I (Chemotherapy, Nivolumab, Radiation)

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

Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)

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

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 I (Chemotherapy, Nivolumab, Radiation)487
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)483

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Chemotherapy, Nivolumab, Radiation)52Not reportedNot reportedNot reportedNot reported
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)91Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        52
      2. group Id
        OG001
        value
        91
denoms
  1. counts
    1. group Id
      OG000
      value
      487
    2. group Id
      OG001
      value
      483
    units
    Participants
description
Will be reported as count of participants who have experienced an EFS event or death at two years. EFS Events are defined as: * Disease progression/relapse * Administration of non-protocol specified systemic anti-lymphoma therapy (i.e. salvage therapy) at any time after initiation of protocol therapy. * Administration of any non-protocol specified radiation therapy at any time afterinitiation of protocol therapy Will be estimated using Kaplan-Meier method and compared between treatment arms using cox regression model.
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
    OG000
    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
    OG001
    title
    Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)
param Type
COUNT_OF_PARTICIPANTS
population Description
All the patients who underwent randomization except for those who were deemed to be ineligible by pathology review or owing to violation of the eligibility criteria.
reporting Status
POSTED
time Frame
From date of registration to date of first occurrence of EFS event, assessed at 2 years
title
Event-free Survival (EFS)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice