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NCT01193842 · OUTCOME

Change in CD8 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
cells/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 CD8 counts.

Analysis population: Eligible participants who returned for follow-up 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

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 14
Phase I: VR-DA-EPOCH, Dose Level 25
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 14
Phase I: VR-DA-EPOCH, Dose Level 25
Phase I: VR-CHOP, Dose Level 11
Values in cells/mm^3 · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase I: VR-DA-EPOCH, Dose Level 135.5Not reported-348.5356.5Not reported
Phase I: VR-DA-EPOCH, Dose Level 2-115Not reported-16275Not reported
Phase I: VR-CHOP, Dose Level 1-172Not reported-172-172Not reported
Treatment discontinuation

Analysis denominator · Participants

GroupSource count
Phase I: VR-DA-EPOCH, Dose Level 14
Phase I: VR-DA-EPOCH, Dose Level 25
Phase I: VR-CHOP, Dose Level 11
Values in cells/mm^3 · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase I: VR-DA-EPOCH, Dose Level 1-164.5Not reported-962.5198.5Not reported
Phase I: VR-DA-EPOCH, Dose Level 2211Not reported18359Not reported
Phase I: VR-CHOP, Dose Level 1-81Not reported-81-81Not 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 cells/mm^3 · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase I: VR-DA-EPOCH, Dose Level 1-56Not reported-177443Not reported
Phase I: VR-DA-EPOCH, Dose Level 2275Not reported-152728Not reported
Phase I: VR-CHOP, Dose Level 1-16Not reported-16-16Not 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 cells/mm^3 · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase I: VR-DA-EPOCH, Dose Level 1604Not reported604604Not reported
Phase I: VR-DA-EPOCH, Dose Level 2154Not reported-97692Not reported
Phase I: VR-CHOP, Dose Level 1128Not reported128128Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -348.5
        upper Limit
        356.5
        value
        35.5
      2. group Id
        OG001
        lower Limit
        -162
        upper Limit
        75
        value
        -115
      3. group Id
        OG002
        lower Limit
        -172
        upper Limit
        -172
        value
        -172
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    End of cycle 2
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -962.5
        upper Limit
        198.5
        value
        -164.5
      2. group Id
        OG001
        lower Limit
        18
        upper Limit
        359
        value
        211
      3. group Id
        OG002
        lower Limit
        -81
        upper Limit
        -81
        value
        -81
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      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
        -177
        upper Limit
        443
        value
        -56
      2. group Id
        OG001
        lower Limit
        -152
        upper Limit
        728
        value
        275
      3. group Id
        OG002
        lower Limit
        -16
        upper Limit
        -16
        value
        -16
    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
        604
        upper Limit
        604
        value
        604
      2. group Id
        OG001
        lower Limit
        -97
        upper Limit
        692
        value
        154
      3. group Id
        OG002
        lower Limit
        128
        upper Limit
        128
        value
        128
    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
      4
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      1
    units
    Participants
description
Differences from baseline (specified follow-up assessment minus baseline) in absolute CD8 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
    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 returned for follow-up with evaluable data.
reporting Status
POSTED
time Frame
Baseline up to 12 months
title
Change in CD8 Cell Counts (Phase I)
type
SECONDARY
unit Of Measure
cells/mm^3

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Preserved source evidence · Not medical advice