Trial intelligence / Profile preview

Bexxar in relapsed/refractory Hodgkin's lymphoma

NCT00484874Phase 2

Key facts

Status
Completed
Start
Jun 2007
Primary completion
Jan 2014
Countries
1
Sponsor
Sidney Kimmel Comprehensive Cancer Center
Conditions
Hodgkin lymphoma (HL)
01

Overview

Phase 2, open-label, single-arm trial of tositumomab in Hodgkin lymphoma (HL), sponsored by Sidney Kimmel Comprehensive Cancer Center. Primary endpoints: Maximum Tolerated Dose at 2 years, Overall Response Rate at 12 weeks and 1 more. Started Jun 2007; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Bexxar Arm

    Patients receive a single therapeutic regimen of I-131 Tositumomab.

03

Who it enrols

Adult patients with biopsy-proven relapsed or refractory Hodgkin's lymphoma who have previously undergone transplant or are ineligible for transplant, with adequate organ function and less than 25% bone marrow involvement.

04

Endpoints

Primary

  • Maximum Tolerated Dose

  • Overall Response Rate

  • Complete Response Rate

Secondary

  • Time to Progression

  • Frequency of Visualization of Hodgkin's Lymphoma

  • Tumor Radiation Absorbed Dose

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