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NCT00012298 · OUTCOME

Time to Disease Progression (Phase II)

Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma · Source last updated 2018-08-09

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

Measure
MEDIAN
Unit
years
Interval / dispersion
95% Confidence Interval
Time frame
From registration to the earliest date documentation of>disease progression, assessed up to 5 years

What was measured

Estimated using the method of Kaplan-Meier.

Analysis population: All eligible phase II patients. One out of the 39 phase II patients was deemed ineligible.

Groups in this outcome

Treatment : Dose Level 6

Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

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

Analysis denominator · Participants

GroupSource count
Treatment : Dose Level 638

Reported measurements

Source class 1
Values in years · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment : Dose Level 62Not reported1.6NAUpper 95% confidence interval was not reached.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper 95% confidence interval was not reached.
        group Id
        OG000
        lower Limit
        1.6
        upper Limit
        NA
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    units
    Participants
description
Estimated using the method of Kaplan-Meier.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
    id
    OG000
    title
    Treatment : Dose Level 6
param Type
MEDIAN
population Description
All eligible phase II patients. One out of the 39 phase II patients was deemed ineligible.
reporting Status
POSTED
time Frame
From registration to the earliest date documentation of>disease progression, assessed up to 5 years
title
Time to Disease Progression (Phase II)
type
SECONDARY
unit Of Measure
years

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

Preserved source evidence · Not medical advice