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NCT03220022 · OUTCOME

Overall Survival (OS)

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
2 years

What was measured

OS will be estimated using Kaplan Meier method, as well as, their corresponding 95% confidence intervals.

Analysis population: Participants received study treatment (ibrutinib plus R-da-EPOCH)

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

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose-finding Cohort66.7Not reported5.494.5Not reported
Dose Expansion Cohort85Not reported67.693.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.4
        upper Limit
        94.5
        value
        66.7
      2. group Id
        OG001
        lower Limit
        67.6
        upper Limit
        93.5
        value
        85
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      40
    units
    Participants
description
OS will be estimated using Kaplan Meier method, as well as, their corresponding 95% confidence intervals.
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
Participants received study treatment (ibrutinib plus R-da-EPOCH)
reporting Status
POSTED
time Frame
2 years
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice