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NCT03220022 · OUTCOME

Response 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 5 years

What was measured

Responses are tabulated by gene expression profiling (GEP) (germinal center B-cell \[GCB\], activated B-cell \[ABC\], unclassifiable) and immunohistochemistry \[IHC\] (GCB, non-GCB).

Analysis population: Participants who received study treatment

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 Cohort35

Reported measurements

complete response rate (GCB DLBCL)

Analysis denominator · Participants

GroupSource count
Dose-finding Cohort2
Dose Expansion Cohort17
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose-finding Cohort2Not reportedNot reportedNot reportedNot reported
Dose Expansion Cohort9Not reportedNot reportedNot reportedNot reported
complete response rate (Non-GCB DLBCL)

Analysis denominator · Participants

GroupSource count
Dose-finding Cohort0
Dose Expansion Cohort13
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose-finding Cohort0Not reportedNot reportedNot reportedNot reported
Dose Expansion Cohort5Not reportedNot reportedNot reportedNot reported
complete response rate (Inconclusive/Not done)

Analysis denominator · Participants

GroupSource count
Dose-finding Cohort1
Dose Expansion Cohort5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose-finding Cohort0Not reportedNot reportedNot reportedNot reported
Dose Expansion Cohort3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        9
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    complete response rate (GCB DLBCL)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        13
      units
      Participants
    title
    complete response rate (Non-GCB DLBCL)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    complete response rate (Inconclusive/Not done)
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      35
    units
    Participants
description
Responses are tabulated by gene expression profiling (GEP) (germinal center B-cell \[GCB\], activated B-cell \[ABC\], unclassifiable) and immunohistochemistry \[IHC\] (GCB, non-GCB).
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
COUNT_OF_PARTICIPANTS
population Description
Participants who received study treatment
reporting Status
POSTED
time Frame
Up to 5 years
title
Response by Lymphoma Cell-of-origin (COO) Assessment
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice