Status:
COMPLETED
Safety and Efficacy of Bexxar Therapy in the Treatment of Relapsed/Residual B-Cell Lymphoma After Autologous Transplant
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
B-cell Lymphoma
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 thera...
Detailed Description
High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) has become the standard of care for relapsed/refractory chemotherapy-sensitive non-Hodgkin's lymphomas (NHL). However, on...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00434629
Start Date
February 1 2007
End Date
May 1 2015
Last Update
August 17 2016
Active Locations (1)
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1
Abramson Cancer Center, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104