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NCT00989586 · OUTCOME

Progression-free Survival (PFS)

Veltuzumab and Milatuzumab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma · Source last updated 2017-02-06

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
up to 2 years

What was measured

Progression is defined using International Response Criteria (Cheson JCO 2007), as a \>= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis, or the size of other lesions (eg, splenic or hepatic nodules), or the appearance of new lesions.

Groups in this outcome

All Patients From Phase I and Phase II

Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4. Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy.

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

Analysis denominator · Participants

GroupSource count
All Patients From Phase I and Phase II34

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Patients From Phase I and Phase II4.7Not reported2.29.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.2
        upper Limit
        9.3
        value
        4.7
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    units
    Participants
description
Progression is defined using International Response Criteria (Cheson JCO 2007), as a \>= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis, or the size of other lesions (eg, splenic or hepatic nodules), or the appearance of new lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4. Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy.
    id
    OG000
    title
    All Patients From Phase I and Phase II
param Type
MEDIAN
reporting Status
POSTED
time Frame
up to 2 years
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice