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NCT01805037 · OUTCOME

Time to Initiation of Cytotoxic Chemotherapy

Brentuximab Vedotin + Rituximab as Frontline Therapy for Pts w/ CD30+ and/or EBV+ Lymphomas · Source last updated 2021-09-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
number of days
Interval / dispersion
Not reported
Time frame
Up to 3 years from treatment discontinuation

What was measured

Time to initiation of cytotoxic chemotherapy will be defined as the time elapsed between study treatment initiation, and time of first non-targeted cytotoxic chemotherapy (off study treatment). Time to cytotoxic chemotherapy will be evaluated in all patients who receive at least one dose of study treatment.

Analysis population: Follow-up data for time to initiation of cytotoxic chemotherapy was collected for only 5 patients. That data is reported below.

Groups in this outcome

Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)

Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.

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

Analysis denominator · Participants

GroupSource count
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)5

Reported measurements

Patient 1
Values in number of days · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)35Not reportedNot reportedNot reportedNot reported
Patient 2
Values in number of days · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)147Not reportedNot reportedNot reportedNot reported
Patient 3
Values in number of days · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)38Not reportedNot reportedNot reportedNot reported
Patient 4
Values in number of days · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)184Not reportedNot reportedNot reportedNot reported
Patient 5
Values in number of days · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)66Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        35
    title
    Patient 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        147
    title
    Patient 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        38
    title
    Patient 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        184
    title
    Patient 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        66
    title
    Patient 5
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Time to initiation of cytotoxic chemotherapy will be defined as the time elapsed between study treatment initiation, and time of first non-targeted cytotoxic chemotherapy (off study treatment). Time to cytotoxic chemotherapy will be evaluated in all patients who receive at least one dose of study treatment.
groups
  1. description
    Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
    id
    OG000
    title
    Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)
param Type
NUMBER
population Description
Follow-up data for time to initiation of cytotoxic chemotherapy was collected for only 5 patients. That data is reported below.
reporting Status
POSTED
time Frame
Up to 3 years from treatment discontinuation
title
Time to Initiation of Cytotoxic Chemotherapy
type
SECONDARY
unit Of Measure
number of days

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

Preserved source evidence · Not medical advice