NCT02494700Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 15 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 8 Jul 2015
- Start date
- 6 Jul 2015
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Follicular lymphoma, Mantle cell lymphoma
- NCT number
- NCT02494700
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 50
- From 6 Jul 2015 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients treated with chemotherapy for lymphoma within 4 weeks of protocol enrollment (including Rituxan).
- Patients with a history of prior radiation to the orbit if re-treatment would exceed known orbital tolerance.
Other
- 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 pre-existing retinopathy.
- Patients who are pregnant.
- Patients with active lupus or scleroderma are ineligible
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.