Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03220022 · OUTCOME

Percentage of Participants Who Receive Two or More Cycles of Combination Chemotherapy, and Are Able to Continue on a Minimum Dose Level of Cyclophosphamide of -1 and Above After Dose Adjustments

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

Hematologic toxicities will be calculated.

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 Cohort40

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose-finding Cohort3Not reportedNot reportedNot reportedNot reported
Dose Expansion Cohort38Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        38
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      40
    units
    Participants
description
Hematologic toxicities will be calculated.
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
Percentage of Participants Who Receive Two or More Cycles of Combination Chemotherapy, and Are Able to Continue on a Minimum Dose Level of Cyclophosphamide of -1 and Above After Dose Adjustments
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice