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NCT00989586 · OUTCOME

Fcγ-receptor Polymorphism Response to Treatment

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
up to 2 years

What was measured

The relationship between overall response rate (ORR) and Fcy receptor status. A two-sided chi-square test or exact test with α = 0.05 will be used to test the homogeneity of the ORR among the three genotypes.

Analysis population: This data is not available due to analysis was not performed. The response rate was to low for the analysis to yield results to report for this trial.

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 II0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
The relationship between overall response rate (ORR) and Fcy receptor status. A two-sided chi-square test or exact test with α = 0.05 will be used to test the homogeneity of the ORR among the three genotypes.
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
population Description
This data is not available due to analysis was not performed. The response rate was to low for the analysis to yield results to report for this trial.
reporting Status
POSTED
time Frame
up to 2 years
title
Fcγ-receptor Polymorphism Response to Treatment
type
SECONDARY

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

Preserved source evidence · Not medical advice