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NCT00012298 · OUTCOME

Tumor Response Rate (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
NUMBER
Unit
percentage of patients with response
Interval / dispersion
95% Confidence Interval
Time frame
Assessed up to 5 years

What was measured

Calculated by the number of tumor responses divided by the total number of evaluable patients. An exact binomial confidence interval will be calculated.

Analysis population: All eligible phase II patients. One 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 percentage of patients with response · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment : Dose Level 689.5Not reported75.297.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        75.2
        upper Limit
        97.1
        value
        89.5
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    units
    Participants
description
Calculated by the number of tumor responses divided by the total number of evaluable patients. An exact binomial confidence interval will be calculated.
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
NUMBER
population Description
All eligible phase II patients. One of the 39 phase II patients was deemed ineligible
reporting Status
POSTED
time Frame
Assessed up to 5 years
title
Tumor Response Rate (Phase II)
type
SECONDARY
unit Of Measure
percentage of patients with response

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

Preserved source evidence · Not medical advice