Safety and Efficacy of Bexxar Therapy in the Treatment of Relapsed/Residual B-Cell Lymphoma After Autologous Transplant
Completed · Phase 1
Conditions studied: B-cell Lymphoma, Non-Hodgkin's Lymphoma
In brief
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.
Key facts
- Study ID
- NCT00434629
- Run by
- University of Pennsylvania
- People needed
- 16
- Starts
- 2007-02-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2016-08-17
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Abramson Cancer Center, University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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