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NCT03220022 · OUTCOME

Average Number of Days Per Cycle Participants Are Able to Stay on Planned Dose of Ibrutinib

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
MEDIAN
Unit
Days
Interval / dispersion
Full Range
Time frame
Up to 5 years

What was measured

Average number of days will be calculated.

Analysis population: Participants who received ibrutinib

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 Days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose-finding Cohort21Not reported021Not reported
Dose Expansion Cohort17Not reported021Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        21
        value
        21
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        21
        value
        17
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      40
    units
    Participants
description
Average number of days will be calculated.
dispersion Type
Full Range
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
MEDIAN
population Description
Participants who received ibrutinib
reporting Status
POSTED
time Frame
Up to 5 years
title
Average Number of Days Per Cycle Participants Are Able to Stay on Planned Dose of Ibrutinib
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice