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NCT03220022 · OUTCOME

Recommended Phase II Dose (RP2D) of Ibrutinib in Combination With Chemotherapy

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 21 days

What was measured

Will be descriptive and will be reported in tabular format with the appropriate summary statistics (count and percentage). In the dose-finding portion, the number of DLTs identified among the DLT-evaluable subjects will be listed and summarized by dose level. The safety variables will be listed and summarized for (1) subjects in the dose-finding portion, (2) subjects in the DEC, and (3) all subjects in the study.

Analysis population: Participants who receive 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. RP2D is dose level which DLT rate is less than 33%.

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

Reported measurements

Source class 1

No of participants who experience DLTs at ibrutinib 560mg

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose-finding Cohort0Not reportedNot reportedNot reportedNot reported

No of participants who do not experience DLTs at ibrutinib 560mg

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose-finding Cohort3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      title
      No of participants who experience DLTs at ibrutinib 560mg
    2. measurements
      1. group Id
        OG000
        value
        3
      title
      No of participants who do not experience DLTs at ibrutinib 560mg
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    units
    Participants
description
Will be descriptive and will be reported in tabular format with the appropriate summary statistics (count and percentage). In the dose-finding portion, the number of DLTs identified among the DLT-evaluable subjects will be listed and summarized by dose level. The safety variables will be listed and summarized for (1) subjects in the dose-finding portion, (2) subjects in the DEC, and (3) all subjects in the study.
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. RP2D is dose level which DLT rate is less than 33%.
    id
    OG000
    title
    Dose-finding Cohort
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants who receive study treatment
reporting Status
POSTED
time Frame
Up to 21 days
title
Recommended Phase II Dose (RP2D) of Ibrutinib in Combination With Chemotherapy
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice