Clinical trial · Interventional
Safety and Efficacy Study of I-131 Tositumomab in Patients With Relapsed/Refractory Hodgkin's Lymphoma
A Phase I/II Study of I-131 Tositumomab in Patients With Relapsed/Refractory Hodgkin's Lymphoma
NCT00484874CI-TRIAL-00034065completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to find the highest safe dose of Iodine-131 Tositumomab (Bexxar®) that can be given to patients who have relapsed/refractory Hodgkin's lymphoma, what side effects these patients get when they take Bexxar® and if Bexxar® is effective in treating relapsed/refractory Hodgkin's lymphoma. Bexxar® works by delivering doses of radiation to cancer cells.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| I-131 Tositumomab therapeutic regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A Single Dose of I-131 Tositumomab
- description
- I-131 Tositumomab therapeutic regimen given to patients with relapsed/refractory Hodgkin's lymphoma who have or have not undergone transplant.
- interventionNames
- Drug: I-131 Tositumomab therapeutic regimen
Primary outcomes (2)
- measure
- Non-myeloablative Maximum Tolerated Dose of I-131 Tositumomab That Can be Given to Patients With Relapsed/Refractory Hodgkin's Lymphoma.
- timeFrame
- 2 years
- measure
- Overall and Complete Response Rates
- timeFrame
- 12 weeks post therapy
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CTI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-proven Hodgkin's lymphoma that is relapsed or refractory and the patient has previously had a transplant or is ineligible for transplant * All stages and histologic subtypes of Hodgkin's lymphoma * Malignant cells may be CD20+ or CD20- * May have previously had either a non-myeloablative or myeloablative allogeneic or autologous stem cell transplant * If prior history of greater than 1 transplant, eligible if other entry criteria are met * No upper limit on the amount of prior chemotherapy * Must be at least 4 weeks out from their most recent chemotherapy or radiation therapy, 6 weeks if the last regimen included BCNU, or mitomycin * Age 18 or greater * Karnofsky performance status ≥ 60 * Organ and marrow function within 4 weeks of registration on the protocol as defined below: * Leukocytes \>2,000/mm3 * Absolute neutrophil count \>1,000/ mm3 * Platelets \>75,000/ mm3 * Hemoglobin \>7 g/dL * Creatinine \<2.5 mg/dL * Less than 25% bone marrow involvement with Hodgkin's lymphoma within 4 weeks of registration on the protocol * If female, not pregnant or breast feeding * Ability to understand and the willingness to sign a written informed consent document * At least one measurable target lesion, measuring 1.5 cm in at least one dimension by standard CT imaging which is FDG -avid on PET/CT. * 2-year expected survival from other diseases Exclusion Criteria: * Receiving any other investigational agents at the same time * Hypocellular bone marrow (less than or equal to 10% cellularity) or marked decrease in any one (or more) hematopoietic precursor within 4 weeks of registration on the protocol * Inability to follow basic radiation safety precautions * Active infections requiring intravenous antibiotics until after resolution of the infection
References
Publications (0)
Data not yet available
No reference posted for this study.