Trial intelligence / Profile preview

PK of Fission-Derived Iodine I 131 Tositumomab in NHL

NCT00062894Phase 2

Key facts

Status
Completed
Start
Apr 2003
Countries
1
Sponsor
GSK
Modality
Monoclonal Antibodies
Conditions
follicular lymphoma (FL)Transformed Follicular Lymphoma (tFL)
01

Overview

Phase 2, open-label, single-arm trial of iodine i 131 tositumomab in follicular lymphoma (FL) and Transformed Follicular Lymphoma (tFL), sponsored by GSK. Primary endpoint: Blood Pharmacokinetics. Started Apr 2003; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • I-131 Tositumomab

    Patients receive dosimetric fission-derived I-131 Tositumomab followed by therapeutic tellurium-derived I-131 Tositumomab.

03

Who it enrols

Adult patients with previously untreated or relapsed follicular or transformed follicular lymphoma, Stage III/IV, with adequate organ function and no prior radioimmunotherapy.

04

Endpoints

Primary

  • Blood Pharmacokinetics

Secondary

  • Total Body Clearance

  • Tumor and Organ Dosimetry

  • Biodistribution

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