Clinical trial · Interventional
Safety and Efficacy of Bexxar Therapy in the Treatment of Relapsed/Residual B-Cell Lymphoma After Autologous Transplant
A Phase I Study of Bexxar® (Tositumomab and 131I-Tositumomab) Radioimmunotherapy in Patients With Relapsed or Residual CD20 Antigen-Expressing B-Cell Lymphomas Following Autologous Hematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bexxar | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- dose-limiting toxicity
- timeFrame
- Week 7 after Bexxar
- measure
- maximum tolerated dose
- timeFrame
- Week 7 after Bexxar
Secondary outcomes (3)
- measure
- overall response rate
- timeFrame
- Week 13 after Bexxar
- measure
- progression-free survival
- timeFrame
- 5 years after Bexxar
- measure
- time to treatment failure
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available