Clinical trial · Interventional
Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy
Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma
NCT00490490CI-TRIAL-00026680terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low Accrual
Summary
Brief summary (as posted)
The purpose of the study is to assess the response rate of patients with relapsed or refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma to Iodine-131 (I-131) tositumomab (Bexxar) therapy plus local palliative radiation therapy (XRT).
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 |
|---|---|---|---|
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bexxar (tositumomab) | Drug | — | UNRESOLVED |
| External beam radiotherapy (XRT) | Procedure | — | UNRESOLVED |
| Potassium Iodide (KI) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tositumomab + XRT + KI
- description
- Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
- interventionNames
- Drug: Bexxar (tositumomab)
- Procedure: External beam radiotherapy (XRT)
- Drug: Potassium Iodide (KI)
Primary outcomes (1)
- measure
- Complete Response (CR) Rate
- timeFrame
- 12 weeks
- description
- Participants assessed for by the following Complete Response (CR) criteria CR or Functional CR * No evidence of disease and symptoms * Any macroscopic nodules detected in any organs no longer present. * Any palpable lymph node is normal and greatest diameter is \< 1.0 cm. * The enlarged organs decreased in size and not palpable * The bone marrow biopsy and aspirate are negative for disease * Negative for disease by PET-scan (functional CR) CR Unconfirmed (CRu) criteria * No evidence of disease and symptoms * Any lymph node mass \> 1.0 cm\^2 diameter has regressed is size by more than 75%. * No macroscopic nodules in any organs * Any palpable lymph node is normal and greatest diameter is \< 1.0 cm. * The bone marrow biopsy and aspirate are negative for disease * The bone marrow biopsy may have increased number or size of lymphoid aggregates without cytologic or architectural atypia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
INCLUSION CRITERIA * Histologically confirmed low grade CD20+ B cell non-Hodgkin lymphoma (NHL) patients who have relapsed after chemotherapy or are chemotherapy resistant and have one or more sites of disease measuring more than 5 cm. * The patients must have failed at least one chemotherapy regimen * No anticancer treatment for three weeks prior to study initiation (six weeks if Rituximab, nitrosourea or Mitomycin C) * Fully recovered from all toxicities associated with prior surgery, radiation, chemotherapy or immunotherapy * An institutional review board- (IRB)-approved signed informed consent * Age 19 years or older * Expected survival of at least 6 months * Prestudy Performance Status of 0, 1 or 2 according to the World Health Organization (WHO) * Absolute neutrophil count (ANC) of at least 1,500/mm³ * Platelet count at least 100,000/mm³ * Hct \> 30% * Hgb \> 9.0 gm * Bilirubin ≤ 2.0 * Creatinine ≤ 2.0 * Bone marrow involvement with lymphoma less than 25% (bilateral bone marrow) within 6 weeks of enrollment * Acceptable birth control method for men and women EXCLUSION CRITERIA * Disease progression within 3 months of last chemotherapy * Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell rescue * Platelet count less than 100,000/mm³ * Hypocellular bone marrow (≤ 15% cellularity) * Marked reduction in bone marrow precursors of one or more cell lines * History of failed stem cell collection * Prior treatment with fludarabine * Prior radioimmunotherapy * Presence of central nervous system (CNS) lymphoma * HIV or AIDS-related lymphoma * Evidence of myelodysplasia on bone marrow biopsy * Abnormal bone marrow cytogenetics * Patients who have received prior external beam radiation therapy to more than 25% of active bone marrow * Patients who have received filgrastim * Sargramostim therapy within 3 weeks prior to treatment * Presence of human anti-mouse antibody (HAMA) reactivity in patients with prior exposure to murine antibodies or proteins * Serious nonmalignant disease or infection, which, in the opinion of the investigator and/or sponsor, would compromise other protocol objectives * Another primary malignancy (other than squamous cell and basal cell cancer of the skin, in situ carcinoma of the cervix, or treated prostate cancer with stable prostate-specific antigen, PSA) for which the patients has not been disease free for at least 3 years * Major surgery, other than diagnostic surgery within 4 weeks * Pleural effusion * Pregnant * Lactating
References
Publications (0)
Data not yet available
No reference posted for this study.