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NCT03907488 · OUTCOME

Progression Free Survival (PFS)

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 observation of progressive disease, or death due to any cause, assessed at 2 years

What was measured

Will be reported as the number of participants who have experienced death or progression, measured at two years. Progression will be measured according to the 2014 Lugano classification. Will test the null hypothesis (HR=1) for PFS using stratified log-rank test with a one-sided alpha of 0.021. The analysis will be based on modified intent-to-treat and will include all eligible patients as randomized regardless of treatment received. The one-sided alpha of .021 will control of the overall type-one error of the study (including the 2 interim superiority analyses) to be less than .025.

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)41Not reportedNot reportedNot reportedNot reported
Arm II (Chemotherapy, Brentuximab Vedotin, Radiation)81Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    The primary analysis of PFS used a stratified log rank test statistic and is reported as two-sided test. Stratified Cox regression was used to estimate treatment hazard ratios for treatment effect. 95% two-sided intervals are reported. The Kaplan-Meier method was used to estimate PFS curves.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.005
    p Value Comment
    One sided P-value
    statistical Method
    Log Rank
Complete source fields
analyses
  1. group Description
    The primary analysis of PFS used a stratified log rank test statistic and is reported as two-sided test. Stratified Cox regression was used to estimate treatment hazard ratios for treatment effect. 95% two-sided intervals are reported. The Kaplan-Meier method was used to estimate PFS curves.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.005
    p Value Comment
    One sided P-value
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        41
      2. group Id
        OG001
        value
        81
denoms
  1. counts
    1. group Id
      OG000
      value
      487
    2. group Id
      OG001
      value
      483
    units
    Participants
description
Will be reported as the number of participants who have experienced death or progression, measured at two years. Progression will be measured according to the 2014 Lugano classification. Will test the null hypothesis (HR=1) for PFS using stratified log-rank test with a one-sided alpha of 0.021. The analysis will be based on modified intent-to-treat and will include all eligible patients as randomized regardless of treatment received. The one-sided alpha of .021 will control of the overall type-one error of the study (including the 2 interim superiority analyses) to be less than .025.
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 observation of progressive disease, or death due to any cause, assessed at 2 years
title
Progression Free Survival (PFS)
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice