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NCT00073918 · OUTCOME

Progression-free Survival

Iodine I 131 Tositumomab, Etoposide and Cyclophosphamide Followed by Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma · Source last updated 2017-08-18

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
At year 3

What was measured

Kaplan-Meier estimate of progression-free survival at 3 years will be used as the primary determinant of potential efficacy.

Groups in this outcome

Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)

RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4. CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2. AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0. cyclophosphamide: Given IV etoposide: Given IV iodine I 131 tositumomab: Given IV quality-of-life assessment: Ancillary study peripheral blood stem cell transplantation: Undergo ASCT given via central catheter

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 (Radio Labeled Monoclonal Antibody, Chemotherapy)107

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)56Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        56
denoms
  1. counts
    1. group Id
      OG000
      value
      107
    units
    Participants
description
Kaplan-Meier estimate of progression-free survival at 3 years will be used as the primary determinant of potential efficacy.
groups
  1. description
    RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4. CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2. AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0. cyclophosphamide: Given IV etoposide: Given IV iodine I 131 tositumomab: Given IV quality-of-life assessment: Ancillary study peripheral blood stem cell transplantation: Undergo ASCT given via central catheter
    id
    OG000
    title
    Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
param Type
NUMBER
reporting Status
POSTED
time Frame
At year 3
title
Progression-free Survival
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice