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NCT01193842 · OUTCOME

Changes in Epstein-Barr Virus (EBV) Viral Load

Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas · Source last updated 2023-11-21

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

Measure
MEDIAN
Unit
IU/mL
Interval / dispersion
Inter-Quartile Range
Time frame
Baseline up to 12 months

What was measured

Differences from baseline (specified follow-up assessment minus baseline) in EBV viral load.

Analysis population: Median Change from the baseline and IQR were calculated. The measurement unit is IU/mL.

Groups in this outcome

Phase II, VR-DA-EPOCH

Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle).

Phase II, DA-R-EPOCH

Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat

Phase I: VR-DA-EPOCH, Dose Level 1

Arm A (VR-DA-EPOCH) with Vorinostat at 300mg once a day on days 1-5 of a cycle (Phase I dose Level 1)

Phase I: VR-DA-EPOCH, Dose Level 2

Arm A (VR-DA-EPOCH) with Vorinostat at 400mg once a day on days 1-5 of a cycle (Phase I dose Level 1)

Phase I: VR-CHOP, Dose Level 1

Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.

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

Analysis denominator · Participants

GroupSource count
Phase II, VR-DA-EPOCH16
Phase II, DA-R-EPOCH19
Phase I: VR-DA-EPOCH, Dose Level 11
Phase I: VR-DA-EPOCH, Dose Level 21
Phase I: VR-CHOP, Dose Level 10

Reported measurements

End of Cycle 2

Analysis denominator · Participants

GroupSource count
Phase II, VR-DA-EPOCH16
Phase II, DA-R-EPOCH19
Phase I: VR-DA-EPOCH, Dose Level 11
Phase I: VR-DA-EPOCH, Dose Level 21
Phase I: VR-CHOP, Dose Level 10
Values in IU/mL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase II, VR-DA-EPOCH-0.61Not reported-104.10Not reported
Phase II, DA-R-EPOCH0Not reported-0.610Not reported
Phase I: VR-DA-EPOCH, Dose Level 10Not reported00Not reported
Phase I: VR-DA-EPOCH, Dose Level 2-2436.1Not reported-2436.1-2436.1Not reported
At treatment discontinuation

Analysis denominator · Participants

GroupSource count
Phase II, VR-DA-EPOCH11
Phase II, DA-R-EPOCH18
Phase I: VR-DA-EPOCH, Dose Level 11
Phase I: VR-DA-EPOCH, Dose Level 21
Phase I: VR-CHOP, Dose Level 10
Values in IU/mL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase II, VR-DA-EPOCH-2.9Not reported-449.6-0.14Not reported
Phase II, DA-R-EPOCH-0.28Not reported-1.90Not reported
Phase I: VR-DA-EPOCH, Dose Level 10Not reported00Not reported
Phase I: VR-DA-EPOCH, Dose Level 2-1.92Not reported-1.92-1.92Not reported
6-month follow-up

Analysis denominator · Participants

GroupSource count
Phase II, VR-DA-EPOCH6
Phase II, DA-R-EPOCH10
Phase I: VR-DA-EPOCH, Dose Level 11
Phase I: VR-DA-EPOCH, Dose Level 21
Phase I: VR-CHOP, Dose Level 10
Values in IU/mL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase II, VR-DA-EPOCH-1.55Not reported-2.980Not reported
Phase II, DA-R-EPOCH0Not reported-4.874.07Not reported
Phase I: VR-DA-EPOCH, Dose Level 10Not reported00Not reported
Phase I: VR-DA-EPOCH, Dose Level 2-1.92Not reported-1.92-1.92Not reported
12-month follow-up

Analysis denominator · Participants

GroupSource count
Phase II, VR-DA-EPOCH8
Phase II, DA-R-EPOCH11
Phase I: VR-DA-EPOCH, Dose Level 11
Phase I: VR-DA-EPOCH, Dose Level 21
Phase I: VR-CHOP, Dose Level 10
Values in IU/mL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase II, VR-DA-EPOCH-0.56Not reported-228.2-0.07Not reported
Phase II, DA-R-EPOCH-2.7Not reported-4.750Not reported
Phase I: VR-DA-EPOCH, Dose Level 10Not reported00Not reported
Phase I: VR-DA-EPOCH, Dose Level 2-1.15Not reported-1.15-1.15Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -104.1
        upper Limit
        0
        value
        -0.61
      2. group Id
        OG001
        lower Limit
        -0.61
        upper Limit
        0
        value
        0
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        0
        value
        0
      4. group Id
        OG003
        lower Limit
        -2436.1
        upper Limit
        -2436.1
        value
        -2436.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    End of Cycle 2
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -449.6
        upper Limit
        -0.14
        value
        -2.9
      2. group Id
        OG001
        lower Limit
        -1.9
        upper Limit
        0
        value
        -0.28
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        0
        value
        0
      4. group Id
        OG003
        lower Limit
        -1.92
        upper Limit
        -1.92
        value
        -1.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        18
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    At treatment discontinuation
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -2.98
        upper Limit
        0
        value
        -1.55
      2. group Id
        OG001
        lower Limit
        -4.87
        upper Limit
        4.07
        value
        0
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        0
        value
        0
      4. group Id
        OG003
        lower Limit
        -1.92
        upper Limit
        -1.92
        value
        -1.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    6-month follow-up
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -228.2
        upper Limit
        -0.07
        value
        -0.56
      2. group Id
        OG001
        lower Limit
        -4.75
        upper Limit
        0
        value
        -2.7
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        0
        value
        0
      4. group Id
        OG003
        lower Limit
        -1.15
        upper Limit
        -1.15
        value
        -1.15
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    12-month follow-up
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      19
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      0
    units
    Participants
description
Differences from baseline (specified follow-up assessment minus baseline) in EBV viral load.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle).
    id
    OG000
    title
    Phase II, VR-DA-EPOCH
  2. description
    Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
    id
    OG001
    title
    Phase II, DA-R-EPOCH
  3. description
    Arm A (VR-DA-EPOCH) with Vorinostat at 300mg once a day on days 1-5 of a cycle (Phase I dose Level 1)
    id
    OG002
    title
    Phase I: VR-DA-EPOCH, Dose Level 1
  4. description
    Arm A (VR-DA-EPOCH) with Vorinostat at 400mg once a day on days 1-5 of a cycle (Phase I dose Level 1)
    id
    OG003
    title
    Phase I: VR-DA-EPOCH, Dose Level 2
  5. description
    Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
    id
    OG004
    title
    Phase I: VR-CHOP, Dose Level 1
param Type
MEDIAN
population Description
Median Change from the baseline and IQR were calculated. The measurement unit is IU/mL.
reporting Status
POSTED
time Frame
Baseline up to 12 months
title
Changes in Epstein-Barr Virus (EBV) Viral Load
type
SECONDARY
unit Of Measure
IU/mL

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

Preserved source evidence · Not medical advice