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

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: GlaxoSmithKline
• Treatments: Iodine-131 anti-B1 antibody; Tositumomab I-131

Criteria

Inclusion Criteria:

• CD20 positive B-cell lymphoma

• Confirmed relapsed/refractory disease following autologous transplant

• Age ≤ 75 years

• Performance status 0 or 1

• Creatinine ≤ 1.5 or calculated creatinine clearance ≥ 60 ml/min

• Total bilirubin, AST, and ALT ≤ 1.5 x upper limit of normal (unless bilirubin due to Gilbert's)

• No active CNS disease

• No detectable bone marrow involvement by lymphoma on histopathologic bone marrow examination

• Bone marrow cellularity ≥ 15% on histopathologic bone marrow examination

• Availability of adequate stored autologous stem cell product (≥ 2 x 106 CD34+ cells/kg)

Exclusion Criteria:

• Active infection

• Pregnant woman are excluded from the study

• Subjects not using contraceptives are excluded from the study

• ANC ≤ 1,500/μL and/or platelet count ≤ 100,000/μL

• 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.]

• Prior total body radiation therapy

• Positive human anti-mouse antibody (HAMA) testing