Clinical trial · Interventional
External Beam Radiotherapy and Zevalin for Management of Indolent B-Cell Non-Hodgkin's Lymphoma
The Role of Conformal External Beam Radiotherapy in the Management of Patients With Bulky Disease Undergoing Y90-Ibritumomab Tiuxetan (Zevalin) Radio-immunotherapy for Indolent B-cell Non-Hodgkin's Lymphoma
NCT00271050CI-TRIAL-00004211completedPhase 1ClinicalTrials.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 the research study is to learn whether external beam radiation can be used as a safe and effective treatment for patients with bulky (≥ 5cm) sites of non-Hodgkin's lymphoma prior to treatment with 90Y-ibritumomab tiuxetan (Zevalin).
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, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| external beam radiotherapy plus 90-Y ibritumomab tiuxetan | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Other: external beam radiotherapy plus 90-Y ibritumomab tiuxetan
Primary outcomes (1)
- measure
- PET and CT (w/oral and IV contrast)
- timeFrame
- 90 days after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * B-cell non-Hodgkin's lymphoma of one of the following types as defined by the WHO classification: * Small lymphocytic lymphoma/Chronic lymphocytic leukemia * Nodal marginal zone B-cell lymphoma * Extranodal marginal zone B-cell lymphoma * Splenic marginal zone lymphoma * Lymphoplasmacytic lymphoma * Follicular lymphoma * Diffuse large B-cell lymphoma which has transformed from one of the previously listed types of lymphomas * At least one site of lymphoma greater than or equal to 5 cm in any dimension * Received at least one prior therapy * Should show evidence of symptomatology as a result of their disease and/or evidence of progression of their disease. * Measurable disease using Cheson criteria \[23\] for Non-Hodgkin's Lymphoma: a lymph node that is greater than 1 cm in its longest transverse diameter by CT scan should be considered compatible with involvement by NHL * No anti-cancer therapy for four weeks (six weeks if rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy * An IRB-approved signed informed consent * Age greater than or equal to 18 * Expected survival greater than or equal to 3 months * Prestudy performance status of 0, 1, or 2 according to WHO * Absolute neutrophil count (\[segmented neutrophils + bands\] x total WBC) \> 1500/mm3 within two weeks prior to first dose of external beam radiation and also documented again two weeks prior to 90Y-ibritumomab tiuxetan treatment * Platelet counts greater than or equal to 100,000 within two weeks prior to first dose of external beam radiation and also documented again two weeks prior to 90Y-ibritumomab tiuxetan treatment * Bone marrow involvement by NHL less than 26% within six weeks of treatment with 90Y-ibritumomab tiuxetan * Cellularity of bone marrow \> 15% within 6 weeks of study * Female patients who are not pregnant or lactating * Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, abstinence is an acceptable method) Exclusion Criteria: * Prior radioimmunotherapy * Presence of CNS lymphoma * Absolute lymphocyte count ≥ 5000 * HIV or AIDS-related lymphoma * Large pleural effusions or ascites * Total bilirubin \> 2.0 mg/dL * Serum creatinine \> 2.0 mg/dL * Patients who, in the opinion of their oncology team, have prior external beam radiation therapy to \> 25% of active skeletal marrow (either involved field or regional) * Patients who have received G-CSF or GM-CSF therapy within two weeks or pegfilgrastim within 4 weeks prior to treatment * Serious nonmalignant disease or infection which, in the opinion of the investigator, would compromise other protocol objectives * Major surgery, other than diagnostic surgery, within four weeks * Pregnant women or women of child-bearing age who refuse pregnancy tests * Patients who have had prior myeloablative autologous or allogenic stem cell transplantation
References
Publications (30)
- BACKGROUNDFisher RI. Overview of non-Hodgkin's lymphoma: biology, staging, and treatment. Semin Oncol. 2003 Apr;30(2 Suppl 4):3-9. doi: 10.1053/sonc.2003.23797. PMID 12728402
- BACKGROUNDDillman RO. Radiolabeled anti-CD20 monoclonal antibodies for the treatment of B-cell lymphoma. J Clin Oncol. 2002 Aug 15;20(16):3545-57. doi: 10.1200/JCO.2002.02.126. No abstract available. PMID 12177115
- BACKGROUNDGustavsson A, Osterman B, Cavallin-Stahl E. A systematic overview of radiation therapy effects in non-Hodgkin's lymphoma. Acta Oncol. 2003;42(5-6):605-19. doi: 10.1080/02841860310014435. PMID 14596518
- BACKGROUNDTobinai K. Rituximab and other emerging antibodies as molecular target-based therapy of lymphoma. Int J Clin Oncol. 2003 Aug;8(4):212-23. doi: 10.1007/s10147-003-0295-y. PMID 12955576
- BACKGROUNDSeymour JF. New treatment approaches to indolent non-Hodgkin's lymphoma. Semin Oncol. 2004 Feb;31(1 Suppl 2):27-32. PMID 15042532
- BACKGROUNDForero A, Lobuglio AF. History of antibody therapy for non-Hodgkin's lymphoma. Semin Oncol. 2003 Dec;30(6 Suppl 17):1-5. doi: 10.1053/j.seminoncol.2003.10.002. PMID 14710396
- BACKGROUNDMcLaughlin P, Grillo-Lopez AJ, Link BK, Levy R, Czuczman MS, Williams ME, Heyman MR, Bence-Bruckler I, White CA, Cabanillas F, Jain V, Ho AD, Lister J, Wey K, Shen D, Dallaire BK. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998 Aug;16(8):2825-33. doi: 10.1200/JCO.1998.16.8.2825. PMID 9704735
- BACKGROUNDCheson BD. Radioimmunotherapy of non-Hodgkin lymphomas. Blood. 2003 Jan 15;101(2):391-8. doi: 10.1182/blood-2002-06-1793. Epub 2002 Sep 19.