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NCT00012298 · OUTCOME

Appearance of Tumor and Normal Organ Images on the Second In2B8 Scan (Phase I)

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
At week 12

What was measured

Calculated from the serial gamma camera images. Compared using a signed-rank-test. Scatter plots will be used to further explore relationships between these residence times and Bland- Altman methods can be used to assess the agreement between the first and second In2B8 scan residence times.

Analysis population: Not collected. Study team decision not to analyze this endpoint.

Groups in this outcome

Treatment (Radiolabeled Monoclonal Antibody Therapy)

Patients receive rituximab IV on days 1 and 8, indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1, and yttrium Y 90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) and interleukin-11 SC until blood counts recover. rituximab: Given IV yttrium Y 90 ibritumomab tiuxetan: Given IV indium In 111 ibritumomab tiuxetan: Given IV oprelvekin: Given subcutaneously filgrastim: Given subcutaneously

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 (Radiolabeled Monoclonal Antibody Therapy)0

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
Calculated from the serial gamma camera images. Compared using a signed-rank-test. Scatter plots will be used to further explore relationships between these residence times and Bland- Altman methods can be used to assess the agreement between the first and second In2B8 scan residence times.
groups
  1. description
    Patients receive rituximab IV on days 1 and 8, indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1, and yttrium Y 90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) and interleukin-11 SC until blood counts recover. rituximab: Given IV yttrium Y 90 ibritumomab tiuxetan: Given IV indium In 111 ibritumomab tiuxetan: Given IV oprelvekin: Given subcutaneously filgrastim: Given subcutaneously
    id
    OG000
    title
    Treatment (Radiolabeled Monoclonal Antibody Therapy)
population Description
Not collected. Study team decision not to analyze this endpoint.
reporting Status
POSTED
time Frame
At week 12
title
Appearance of Tumor and Normal Organ Images on the Second In2B8 Scan (Phase I)
type
SECONDARY

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

Preserved source evidence · Not medical advice