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NCT01805037 · OUTCOME

Median Time to Best Response

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
MEDIAN
Unit
number of days
Interval / dispersion
Full Range
Time frame
From start of treatment, every 12 weeks for up to 1 year on treatment (Range of cycles attempted from induction, +/- consolidation, + maintenance = 1-17 cycles) Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks

What was measured

Time to best response = the number of days from treatment initiation to best response (complete response/CR or partial response/PR). Best response assessed by CT or PET/CT according to the Revised Response Criteria for Malignant Lymphoma (Cheson et. al). Responses include Complete Response (CR), Partial Response (PR), and Stable Disease (SD). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present before therapy. If a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on CT to normal size. PR: At least a 50% decrease in sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. SD: neither CR or PR, or progressive disease (PD). PD: Appearance of new lesion \> 1.5 cm in any axis, or at least a 50% increase from nadir in the diameter of any previously involved nodes.

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)20

Reported measurements

Source class 1
Values in number of days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)28Not reported23151Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23
        upper Limit
        151
        value
        28
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
Time to best response = the number of days from treatment initiation to best response (complete response/CR or partial response/PR). Best response assessed by CT or PET/CT according to the Revised Response Criteria for Malignant Lymphoma (Cheson et. al). Responses include Complete Response (CR), Partial Response (PR), and Stable Disease (SD). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present before therapy. If a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on CT to normal size. PR: At least a 50% decrease in sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. SD: neither CR or PR, or progressive disease (PD). PD: Appearance of new lesion \> 1.5 cm in any axis, or at least a 50% increase from nadir in the diameter of any previously involved nodes.
dispersion Type
Full Range
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
MEDIAN
reporting Status
POSTED
time Frame
From start of treatment, every 12 weeks for up to 1 year on treatment (Range of cycles attempted from induction, +/- consolidation, + maintenance = 1-17 cycles) Induction = 4 weeks, consolidation = 4 weeks, 1 maintenance cycle = 3 weeks
title
Median Time to Best Response
type
POST_HOC
unit Of Measure
number of days

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

Preserved source evidence · Not medical advice