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NCT03220022 · OUTCOME

Survival by Lymphoma Cell-of-origin (COO) Assessment

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas · Source last updated 2026-08-11

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
up to 2 years

What was measured

Survival rates (PFS and OS at 1 year and 2 years) are reported by gene expression profiling (GEP) (germinal center B-cell \[GCB\], activated B-cell \[ABC\], unclassifiable) and immunohistochemistry \[IHC\] (GCB, non-GCB).

Analysis population: Survival rate at a specific time point is reported by Lymphoma cell-of-origin (COO) type.

Groups in this outcome

Dose-finding Cohort

Each participant in the dose-finding cohort must have completed at least cycle 1 (or 21 days) of ibrutinib plus rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (EPOCH). Starting dose of ibrutinib is 560 mg PO.

Dose Expansion Cohort

Each participant in the dose expansion cohort may receive treatment for a maximum of 6 cycles (21-day cycle length) of ibrutinib plus rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (EPOCH). MTD of ibrutinib is 560 mg PO.

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

Analysis denominator · Participants

GroupSource count
Dose-finding Cohort3
Dose Expansion Cohort40

Reported measurements

1-yr PFS (GCB DLBCL)

Analysis denominator · Participants

GroupSource count
Dose-finding Cohort2
Dose Expansion Cohort18
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose-finding Cohort50Not reported0.691Not reported
Dose Expansion Cohort94.4Not reported66.699.2Not reported
1-yr PFS (non-GCB DLBCL)

Analysis denominator · Participants

GroupSource count
Dose-finding Cohort0
Dose Expansion Cohort17
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Expansion Cohort83.9Not reported49.495.7Not reported
1-yr PFS (Inconclusive/Not done)

Analysis denominator · Participants

GroupSource count
Dose-finding Cohort1
Dose Expansion Cohort5
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose-finding Cohort0Not reported00Not reported
Dose Expansion Cohort80Not reported20.496.9Not reported
2-yr PFS (GCB DLBCL)

Analysis denominator · Participants

GroupSource count
Dose-finding Cohort2
Dose Expansion Cohort18
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose-finding Cohort50Not reported0.691Not reported
Dose Expansion Cohort88.1Not reported60.296.9Not reported
2-yr PFS (non-GCB DLBCL)

Analysis denominator · Participants

GroupSource count
Dose-finding Cohort0
Dose Expansion Cohort17
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Expansion Cohort75.5Not reported41.691.4Not reported
2-yr PFS (Inconclusive/not done)

Analysis denominator · Participants

GroupSource count
Dose-finding Cohort1
Dose Expansion Cohort5
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose-finding Cohort0Not reported00Not reported
Dose Expansion Cohort80Not reported20.496.9Not reported
1-yr OS (GCB DLBCL)

Analysis denominator · Participants

GroupSource count
Dose-finding Cohort2
Dose Expansion Cohort18
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose-finding Cohort50Not reported0.691Not reported
Dose Expansion Cohort100Not reported100100Not reported
1-yr OS (non-GCB DLBCL)

Analysis denominator · Participants

GroupSource count
Dose-finding Cohort0
Dose Expansion Cohort17
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Expansion Cohort83.9Not reported49.495.7Not reported
1-yr OS (Inconclusive/not done)

Analysis denominator · Participants

GroupSource count
Dose-finding Cohort1
Dose Expansion Cohort5
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose-finding Cohort100Not reported100100Not reported
Dose Expansion Cohort80Not reported20.496.9Not reported
2-yr OS (GCB DLBCL)

Analysis denominator · Participants

GroupSource count
Dose-finding Cohort2
Dose Expansion Cohort18
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose-finding Cohort50Not reported0.691Not reported
Dose Expansion Cohort87.5Not reported58.696.7Not reported
2-yr OS (non-GCB DLBCL)

Analysis denominator · Participants

GroupSource count
Dose-finding Cohort0
Dose Expansion Cohort17
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Expansion Cohort86.9Not reported49.495.7Not reported
2-yr OS (Inconclusive/not done)

Analysis denominator · Participants

GroupSource count
Dose-finding Cohort1
Dose Expansion Cohort5
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose-finding Cohort100Not reported100100Not reported
Dose Expansion Cohort80Not reported20.496.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.6
        upper Limit
        91
        value
        50
      2. group Id
        OG001
        lower Limit
        66.6
        upper Limit
        99.2
        value
        94.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    1-yr PFS (GCB DLBCL)
  2. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        49.4
        upper Limit
        95.7
        value
        83.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    1-yr PFS (non-GCB DLBCL)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
      2. group Id
        OG001
        lower Limit
        20.4
        upper Limit
        96.9
        value
        80
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    1-yr PFS (Inconclusive/Not done)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.6
        upper Limit
        91
        value
        50
      2. group Id
        OG001
        lower Limit
        60.2
        upper Limit
        96.9
        value
        88.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    2-yr PFS (GCB DLBCL)
  5. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        41.6
        upper Limit
        91.4
        value
        75.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    2-yr PFS (non-GCB DLBCL)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
      2. group Id
        OG001
        lower Limit
        20.4
        upper Limit
        96.9
        value
        80
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    2-yr PFS (Inconclusive/not done)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.6
        upper Limit
        91
        value
        50
      2. group Id
        OG001
        lower Limit
        100
        upper Limit
        100
        value
        100
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    1-yr OS (GCB DLBCL)
  8. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        49.4
        upper Limit
        95.7
        value
        83.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    1-yr OS (non-GCB DLBCL)
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        100
        upper Limit
        100
        value
        100
      2. group Id
        OG001
        lower Limit
        20.4
        upper Limit
        96.9
        value
        80
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    1-yr OS (Inconclusive/not done)
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.6
        upper Limit
        91
        value
        50
      2. group Id
        OG001
        lower Limit
        58.6
        upper Limit
        96.7
        value
        87.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    2-yr OS (GCB DLBCL)
  11. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        49.4
        upper Limit
        95.7
        value
        86.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    2-yr OS (non-GCB DLBCL)
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        100
        upper Limit
        100
        value
        100
      2. group Id
        OG001
        lower Limit
        20.4
        upper Limit
        96.9
        value
        80
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    2-yr OS (Inconclusive/not done)
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      40
    units
    Participants
description
Survival rates (PFS and OS at 1 year and 2 years) are reported by gene expression profiling (GEP) (germinal center B-cell \[GCB\], activated B-cell \[ABC\], unclassifiable) and immunohistochemistry \[IHC\] (GCB, non-GCB).
dispersion Type
95% Confidence Interval
groups
  1. description
    Each participant in the dose-finding cohort must have completed at least cycle 1 (or 21 days) of ibrutinib plus rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (EPOCH). Starting dose of ibrutinib is 560 mg PO.
    id
    OG000
    title
    Dose-finding Cohort
  2. description
    Each participant in the dose expansion cohort may receive treatment for a maximum of 6 cycles (21-day cycle length) of ibrutinib plus rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (EPOCH). MTD of ibrutinib is 560 mg PO.
    id
    OG001
    title
    Dose Expansion Cohort
param Type
NUMBER
population Description
Survival rate at a specific time point is reported by Lymphoma cell-of-origin (COO) type.
reporting Status
POSTED
time Frame
up to 2 years
title
Survival by Lymphoma Cell-of-origin (COO) Assessment
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice