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NCT01920932 · OUTCOME

Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control

Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma · Source last updated 2026-05-06

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)

What was measured

To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 (NCT00145600) unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients.

Analysis population: The first 32 evaluable participants enrolled was evaluated.

Groups in this outcome

AEPA Chemotherapy

Ann Arbor stage IIB, IIIB, IVA, or IVB risk participants receive 2 cycles of AEPA chemotherapy (brentuximab vedotin, etoposide, prednisone, doxorubicin)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
AEPA Chemotherapy32

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
AEPA Chemotherapy31.25Not reported18.0447.21Not reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    group Description
    In the historical control (HOD99) 17% of patients had CR at week 8. Sample size for this objective is calculated based on a binomial distribution to test H0: p=17% vs. Ha: p\>17%, where p is the true CR rate after 2 cycles of AEPA. 32 patients are needed to detect 20% increase of CR rate with 80% power and 5% type I error. If it shows efficacy, the response results will be reported, and the study will continue to enroll for a total of 77 patients to assess response and EFS.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value Comment
    The comparison of the complete rate between the first 32 evaluable participants and the historical control of HOD99 unfavorable risk patients was estimated by the binomial proportions test.
    param Type
    Binomial proportions
    param Value
    31.25
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    group Description
    In the historical control (HOD99) 17% of patients had CR at week 8. Sample size for this objective is calculated based on a binomial distribution to test H0: p=17% vs. Ha: p\>17%, where p is the true CR rate after 2 cycles of AEPA. 32 patients are needed to detect 20% increase of CR rate with 80% power and 5% type I error. If it shows efficacy, the response results will be reported, and the study will continue to enroll for a total of 77 patients to assess response and EFS.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value Comment
    The comparison of the complete rate between the first 32 evaluable participants and the historical control of HOD99 unfavorable risk patients was estimated by the binomial proportions test.
    param Type
    Binomial proportions
    param Value
    31.25
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.04
        upper Limit
        47.21
        value
        31.25
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    units
    Participants
description
To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 (NCT00145600) unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients.
dispersion Type
90% Confidence Interval
groups
  1. description
    Ann Arbor stage IIB, IIIB, IVA, or IVB risk participants receive 2 cycles of AEPA chemotherapy (brentuximab vedotin, etoposide, prednisone, doxorubicin)
    id
    OG000
    title
    AEPA Chemotherapy
param Type
NUMBER
population Description
The first 32 evaluable participants enrolled was evaluated.
reporting Status
POSTED
time Frame
After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
title
Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice