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NCT01193842 · OUTCOME

Changes in Absolute CD4 Cell Counts (Phase I)

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
cell/mm^3
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 absolute CD4 counts.

Analysis population: Eligible participants who completed at least 1 cycle of treatment with evaluable data.

Groups in this outcome

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

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

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

Phase I, Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)

Phase I: VR-CHOP, Dose Level 1

Phase I, 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 I: VR-DA-EPOCH, Dose Level 16
Phase I: VR-DA-EPOCH, Dose Level 26
Phase I: VR-CHOP, Dose Level 11

Reported measurements

End of cycle 2

Analysis denominator · Participants

GroupSource count
Phase I: VR-DA-EPOCH, Dose Level 16
Phase I: VR-DA-EPOCH, Dose Level 26
Phase I: VR-CHOP, Dose Level 11
Values in cell/mm^3 · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase I: VR-DA-EPOCH, Dose Level 192Not reported9143Not reported
Phase I: VR-DA-EPOCH, Dose Level 2-9Not reported-4149Not reported
Phase I: VR-CHOP, Dose Level 1-218Not reported-218-218Not reported
Treatment discontinuation

Analysis denominator · Participants

GroupSource count
Phase I: VR-DA-EPOCH, Dose Level 16
Phase I: VR-DA-EPOCH, Dose Level 25
Phase I: VR-CHOP, Dose Level 11
Values in cell/mm^3 · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase I: VR-DA-EPOCH, Dose Level 1-39Not reported-5356Not reported
Phase I: VR-DA-EPOCH, Dose Level 2-29Not reported-3241Not reported
Phase I: VR-CHOP, Dose Level 1-190Not reported-190-190Not reported
6-month follow-up

Analysis denominator · Participants

GroupSource count
Phase I: VR-DA-EPOCH, Dose Level 13
Phase I: VR-DA-EPOCH, Dose Level 25
Phase I: VR-CHOP, Dose Level 11
Values in cell/mm^3 · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase I: VR-DA-EPOCH, Dose Level 176Not reported75181Not reported
Phase I: VR-DA-EPOCH, Dose Level 231Not reported-945Not reported
Phase I: VR-CHOP, Dose Level 1-175Not reported-175-175Not reported
12-month follow-up

Analysis denominator · Participants

GroupSource count
Phase I: VR-DA-EPOCH, Dose Level 11
Phase I: VR-DA-EPOCH, Dose Level 25
Phase I: VR-CHOP, Dose Level 11
Values in cell/mm^3 · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase I: VR-DA-EPOCH, Dose Level 1169Not reported169169Not reported
Phase I: VR-DA-EPOCH, Dose Level 231Not reported-16104Not reported
Phase I: VR-CHOP, Dose Level 1-84Not reported-84-84Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9
        upper Limit
        143
        value
        92
      2. group Id
        OG001
        lower Limit
        -41
        upper Limit
        49
        value
        -9
      3. group Id
        OG002
        lower Limit
        -218
        upper Limit
        -218
        value
        -218
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    End of cycle 2
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -53
        upper Limit
        56
        value
        -39
      2. group Id
        OG001
        lower Limit
        -32
        upper Limit
        41
        value
        -29
      3. group Id
        OG002
        lower Limit
        -190
        upper Limit
        -190
        value
        -190
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Treatment discontinuation
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        75
        upper Limit
        181
        value
        76
      2. group Id
        OG001
        lower Limit
        -9
        upper Limit
        45
        value
        31
      3. group Id
        OG002
        lower Limit
        -175
        upper Limit
        -175
        value
        -175
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    6-month follow-up
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        169
        upper Limit
        169
        value
        169
      2. group Id
        OG001
        lower Limit
        -16
        upper Limit
        104
        value
        31
      3. group Id
        OG002
        lower Limit
        -84
        upper Limit
        -84
        value
        -84
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    12-month follow-up
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      1
    units
    Participants
description
Differences from baseline (specified follow-up assessment minus baseline) in absolute CD4 counts.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Phase I, Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
    id
    OG000
    title
    Phase I: VR-DA-EPOCH, Dose Level 1
  2. description
    Phase I, Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
    id
    OG001
    title
    Phase I: VR-DA-EPOCH, Dose Level 2
  3. description
    Phase I, 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
    OG002
    title
    Phase I: VR-CHOP, Dose Level 1
param Type
MEDIAN
population Description
Eligible participants who completed at least 1 cycle of treatment with evaluable data.
reporting Status
POSTED
time Frame
Baseline up to 12 months
title
Changes in Absolute CD4 Cell Counts (Phase I)
type
SECONDARY
unit Of Measure
cell/mm^3

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Preserved source evidence · Not medical advice