TheranosticTrials.org

Clinical Trial · NCT00434629

Safety and Efficacy of Bexxar Therapy in the Treatment of Relapsed/Residual B-Cell Lymphoma After Autologous Transplant

Overview

Patients with B-cell lymphoma who relapse after autologous transplant tend to have a poor prognosis. Currently, there is no standard treatment for such patients. Bexxar is a radioactive antibody therapy that has shown a 60-80% response rate in non-transplanted patients with relapsed B-cell lymphoma. This study will test the safety and efficacy of Bexxar in the treatment of patients whose B-cell lymphoma has relapsed after an autologous transplant.

Sponsor

University of Pennsylvania

Phase

Phase 1

Contacts

Stephen J. Schuster, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00434629

Drug / Compound

tositumomab

Isotope(s):
Target(s):
  • CD20 antigen
Ligand Class: Antibodies

Eligibility

Inclusion

  • Confirmed relapsed/refractory disease following autologous transplant
  • Bone marrow cellularity ≥ 15% on histopathologic bone marrow examination
  • Performance status 0 or 1
  • Availability of adequate stored autologous stem cell product (≥ 2 x 106 CD34+ cells/kg)
  • No active CNS disease
  • CD20 positive B-cell lymphoma
  • Total bilirubin, AST, and ALT ≤ 1.5 x upper limit of normal (unless bilirubin due to Gilbert's)
  • No detectable bone marrow involvement by lymphoma on histopathologic bone marrow examination
  • Creatinine ≤ 1.5 or calculated creatinine clearance ≥ 60 ml/min

Exclusion

  • Positive human anti-mouse antibody (HAMA) testing
  • Active infection
  • ANC ≤ 1,500/μL and/or platelet count ≤ 100,000/μL
  • Prior total body radiation therapy
  • Subjects not using contraceptives are excluded from the study
  • Life expectancy of ≤ 2 months
  • Prior anti-B-cell radioimmunotherapy (e.g., Zevalin or Bexxar) \[Patients who have received prior anti-B-cell monoclonal antibody therapy (e.g., rituximab or epratuzumab) will NOT be excluded.\]
  • Pregnant woman are excluded from the study