Clinical trial · Interventional
Ultra Low Dose Orbital Radiation Therapy in Treating Patients With Stage I-IV Indolent B-cell Lymphoma or Mantle Cell Lymphoma
Ultra Low Dose 4 Gy Orbital Radiation for Definitive Therapy of Indolent B Cell Lymphoma
NCT02494700CI-TRIAL-00118045active not recruitingPhase 2ClinicalTrials.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)
This phase II trial studies how well ultra low dose orbital radiation therapy works in treating patients with stage I-IV low grade (indolent) B-cell lymphoma or mantle cell lymphoma involving the orbit of the eye (space enclosed by the borders of the eye socket). Orbital radiation therapy uses external beam radiation to destroy cancer cells. Using ultra low dose orbital radiation therapy may be effective in treating indolent B-cell lymphoma or mantle cell lymphoma involving the eye and may have fewer side effects.
Conditions
Conditions (23)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ann Arbor Stage I B-Cell Non-Hodgkin Lymphoma | — | UNRESOLVED | — |
| Ann Arbor Stage I Grade 1 Follicular Lymphoma | — | UNRESOLVED | — |
| Ann Arbor Stage I Grade 2 Follicular Lymphoma | — | UNRESOLVED | — |
| Ann Arbor Stage II B-Cell Non-Hodgkin Lymphoma | — | UNRESOLVED | — |
| Ann Arbor Stage II Grade 1 Follicular Lymphoma | — | UNRESOLVED | — |
| Ann Arbor Stage II Grade 2 Follicular Lymphoma | — | UNRESOLVED | — |
| Ann Arbor Stage III B-Cell Non-Hodgkin Lymphoma | — | UNRESOLVED | — |
| Ann Arbor Stage III Grade 1 Follicular Lymphoma | — | UNRESOLVED | — |
| Ann Arbor Stage III Grade 2 Follicular Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| Orbital Radiation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (low dose orbital EBRT)
- description
- Patients undergo two fractions of low dose orbital EBRT on 2 consecutive days. Patients experiencing stable or progressive disease after 12-16 weeks of EBRT undergo additional low dose orbital EBRT over 10 fractions. Patients experiencing partial response or minimal response 1 year after EBRT also undergo low dose orbital EBRT over 10 fractions.
- interventionNames
- Radiation: External Beam Radiation Therapy
- Drug: Orbital Radiation
Primary outcomes (1)
- measure
- Local orbital control (i.e. local control within the radiation field)
- timeFrame
- Up to 2 years post-radiation
- description
- Local orbital event will be estimated using the Kaplan-Meier method.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients 18 years or older with stage I-IV indolent B cell lymphoma, including MALT and follicular grade I/II. Patients with mantle cell lymphoma will also be included in this study, as mantle cell lymphoma is also radiosensitive, despite it not being an indolent B cell lymphoma. Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) are ineligible. * Patients must have measurable disease within the orbit, either clinically and/or radiographically after biopsy confirmation of B cell lymphoma. * Bilateral ocular adnexal involvement is permitted, if biopsy confirms unilateral disease and there is high clinical suspicion for bilateral disease, biopsy of the contralateral ocular adnexa can be waived. * Female patients of childbearing potential must have a negative serum pregnancy test (βhCG) within 2 weeks of protocol entry. * Planned systemic therapy after orbital radiation therapy is permitted however the timing of systemic therapy will be recorded and patients will be stratified according to receipt of adjuvant systemic therapy. * Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study. * Female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post-menopausal (free from menses \> two years or surgically sterilized). * Patients must have the ability to give informed consent. Exclusion Criteria: * Patients treated with chemotherapy for lymphoma within 4 weeks of protocol enrollment (including Rituxan). * Patients with aggressive B cell lymphoma histology, including diffuse large B cell lymphoma (DLBCL) and grade 3 follicular lymphoma. * Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). * Patients with a history of prior radiation to the orbit if re-treatment would exceed known orbital tolerance. * Patients with pre-existing retinopathy. * Patients who are pregnant. * Patients with active lupus or scleroderma are ineligible
References
Publications (1)
- DERIVEDPinnix CC, Dabaja BS, Gunther JR, Fang PQ, Wu SY, Nastoupil LJ, Strati P, Nair R, Ahmed S, Steiner R, Westin J, Neelapu S, Rodriguez MA, Lee HJ, Wang M, Flowers C, Feng L, Esmaeli B. Response-Adapted Ultralow-Dose Radiation Therapy for Orbital Indolent B-Cell Lymphoma: A Phase 2 Nonrandomized Controlled Trial. JAMA Oncol. 2024 Sep 1;10(9):1195-1203. doi: 10.1001/jamaoncol.2024.2112. PMID 38990564