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NCT00989586 · OUTCOME

Monitor Human Anti-veltuzumab Antibodies and Human Anti-milatuzumab (HAHA)

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
NUMBER
Unit
patients
Interval / dispersion
Not reported
Time frame
up to 36 weeks

What was measured

Patients will be monitored for the development of human anti-veltuzumab antibodies and human anti-milatuzumab antibodies (HAHA).

Analysis population: HAHA titres were assayed for patients in Phase I and Phase II

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 II33

Reported measurements

anti-veltuzumab antibodies
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients From Phase I and Phase II1Not reportedNot reportedNot reportedNot reported
anti-milatuzumab antibodies
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients From Phase I and Phase II0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    anti-veltuzumab antibodies
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    anti-milatuzumab antibodies
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
Patients will be monitored for the development of human anti-veltuzumab antibodies and human anti-milatuzumab antibodies (HAHA).
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
NUMBER
population Description
HAHA titres were assayed for patients in Phase I and Phase II
reporting Status
POSTED
time Frame
up to 36 weeks
title
Monitor Human Anti-veltuzumab Antibodies and Human Anti-milatuzumab (HAHA)
type
SECONDARY
unit Of Measure
patients

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

Preserved source evidence · Not medical advice