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NCT02703272 · OUTCOME

Part 2: Number of Participants With CD79B, CARD11, and MYD Mutations

A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma · Source last updated 2022-12-02

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 4 year and 4 months

What was measured

Number of participants with CD79B, CARD11, and MYD mutations were reported. Blood samples were taken to evaluate the levels of biomarkers such as CD79B, CARD11, and MYD mutations.

Analysis population: Biomarker analyses were conducted on the ITT population. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Groups in this outcome

Part 2: Ibrutinib+CIT (RICE or RVICI)

Participants received ibrutinib based on age group and BSA in combination with CIT (investigator choice of RICE or RVICI) until 3 treatment cycles, transplantation if indicated, or until progressive disease (PD) or unacceptable toxicity. For both regimens, triple intrathecal therapy consisting of methotrexate, corticosteroid, and cytarabine will be administered for central nervous system (CNS) prophylaxis in age-appropriate dosing. Participants of age groups 1-5 years and 6-11 years received ibrutinib 440 mg/m\^2, and age group 12-17 years received Ibrutinib 329 mg/m\^2 (dose selected from Part 1).

Part 2: Chemoimmunotherapy

Participants received CIT (investigator choice of RICE or RVICI) alone based on age group and BSA until 3 treatment cycles, transplantation if indicated, or until PD or unacceptable toxicity. For both regimens, triple intrathecal therapy consisting of methotrexate, corticosteroid, and cytarabine will be administered for CNS prophylaxis in age-appropriate dosing. The RICE regimen was composed of rituximab 750 mg/m\^2, ifosfamide 9 g/m2, carboplatin 635 mg/m\^2, etoposide 300 mg/m\^2, and dexamethasone 100 mg/m\^2. The RVICI regimen was composed of rituximab 750 mg/m\^2, vincristine 1.6 mg/m\^2, idarubicin 20 mg/m\^2, carboplatin 800 mg/m\^2, ifosfamide 10 g/m\^2, and dexamethasone 100 mg/m\^2 (all doses represented as cumulative administered in 1 cycle).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part 2: Ibrutinib+CIT (RICE or RVICI)20
Part 2: Chemoimmunotherapy10

Reported measurements

CD79B
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Ibrutinib+CIT (RICE or RVICI)1Not reportedNot reportedNot reportedNot reported
Part 2: Chemoimmunotherapy0Not reportedNot reportedNot reportedNot reported
CARD11
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Ibrutinib+CIT (RICE or RVICI)1Not reportedNot reportedNot reportedNot reported
Part 2: Chemoimmunotherapy0Not reportedNot reportedNot reportedNot reported
MYD mutation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Ibrutinib+CIT (RICE or RVICI)0Not reportedNot reportedNot reportedNot reported
Part 2: Chemoimmunotherapy0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    CD79B
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    CARD11
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    MYD mutation
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      10
    units
    Participants
description
Number of participants with CD79B, CARD11, and MYD mutations were reported. Blood samples were taken to evaluate the levels of biomarkers such as CD79B, CARD11, and MYD mutations.
groups
  1. description
    Participants received ibrutinib based on age group and BSA in combination with CIT (investigator choice of RICE or RVICI) until 3 treatment cycles, transplantation if indicated, or until progressive disease (PD) or unacceptable toxicity. For both regimens, triple intrathecal therapy consisting of methotrexate, corticosteroid, and cytarabine will be administered for central nervous system (CNS) prophylaxis in age-appropriate dosing. Participants of age groups 1-5 years and 6-11 years received ibrutinib 440 mg/m\^2, and age group 12-17 years received Ibrutinib 329 mg/m\^2 (dose selected from Part 1).
    id
    OG000
    title
    Part 2: Ibrutinib+CIT (RICE or RVICI)
  2. description
    Participants received CIT (investigator choice of RICE or RVICI) alone based on age group and BSA until 3 treatment cycles, transplantation if indicated, or until PD or unacceptable toxicity. For both regimens, triple intrathecal therapy consisting of methotrexate, corticosteroid, and cytarabine will be administered for CNS prophylaxis in age-appropriate dosing. The RICE regimen was composed of rituximab 750 mg/m\^2, ifosfamide 9 g/m2, carboplatin 635 mg/m\^2, etoposide 300 mg/m\^2, and dexamethasone 100 mg/m\^2. The RVICI regimen was composed of rituximab 750 mg/m\^2, vincristine 1.6 mg/m\^2, idarubicin 20 mg/m\^2, carboplatin 800 mg/m\^2, ifosfamide 10 g/m\^2, and dexamethasone 100 mg/m\^2 (all doses represented as cumulative administered in 1 cycle).
    id
    OG001
    title
    Part 2: Chemoimmunotherapy
param Type
COUNT_OF_PARTICIPANTS
population Description
Biomarker analyses were conducted on the ITT population. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Up to 4 year and 4 months
title
Part 2: Number of Participants With CD79B, CARD11, and MYD Mutations
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice