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NCT00006436 · OUTCOME

1 Year Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS)

EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection · Source last updated 2026-08-03

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
95% Confidence Interval
Time frame
1 year

What was measured

1-year PFS is defined as participants who remain free of disease progression or death at one year from study entry. We compared the 1-year PFS of participants with negative results on interim positron emission tomography (PET) scans to those with positive results on interim PET scans. PFS is defined as the time interval from start of treatment to documented evidence of disease progression or death from any cause. Disease progression was assessed by positron emission tomography scans after 2 cycles of therapy using the Deauville criteria. Deauville score of 4 or 5 is considered positive on interim PET scan while a Deauville score of 1 or 2 or 3 is considered negative. The outcomes of the Deauville score was compared to determine PET positive progression free survival.

Analysis population: 27 participants had no PET scan.

Groups in this outcome

Arm 1-Combination Chemo and Biological Therapy

Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles

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 1-Combination Chemo and Biological Therapy41

Reported measurements

Interim PET scan positive 1-year PFS

Analysis denominator · Participants

GroupSource count
Arm 1-Combination Chemo and Biological Therapy13
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm 1-Combination Chemo and Biological Therapy61.5Not reported30.881.8Not reported
Interim PET scan negative 1 year PFS

Analysis denominator · Participants

GroupSource count
Arm 1-Combination Chemo and Biological Therapy28
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm 1-Combination Chemo and Biological Therapy89.3Not reported70.496.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        30.8
        upper Limit
        81.8
        value
        61.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Interim PET scan positive 1-year PFS
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        70.4
        upper Limit
        96.3
        value
        89.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      units
      Participants
    title
    Interim PET scan negative 1 year PFS
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    units
    Participants
description
1-year PFS is defined as participants who remain free of disease progression or death at one year from study entry. We compared the 1-year PFS of participants with negative results on interim positron emission tomography (PET) scans to those with positive results on interim PET scans. PFS is defined as the time interval from start of treatment to documented evidence of disease progression or death from any cause. Disease progression was assessed by positron emission tomography scans after 2 cycles of therapy using the Deauville criteria. Deauville score of 4 or 5 is considered positive on interim PET scan while a Deauville score of 1 or 2 or 3 is considered negative. The outcomes of the Deauville score was compared to determine PET positive progression free survival.
dispersion Type
95% Confidence Interval
groups
  1. description
    Combination chemo and biological therapy Rituximab: 2 doses of rituximab every cycle: first dose on Day 1 and 2nd dose on Day 5 Filgrastim: Filgrastim day 6 until absolute neutrophil count (ANC) reaches 5000 after the nadir, every cycle Etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin hydrochloride (EPOCH): combination chemotherapy: EPOCH every 3 weeks for minimum of 3 cycles and max of 6 cycles
    id
    OG000
    title
    Arm 1-Combination Chemo and Biological Therapy
param Type
NUMBER
population Description
27 participants had no PET scan.
reporting Status
POSTED
time Frame
1 year
title
1 Year Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice