Ann Arbor Stage III Grade 2 Follicular Lymphoma Clinical Trial
Official title:
Ultra Low Dose 4 Gy Orbital Radiation for Definitive Therapy of Indolent B Cell Lymphoma
Verified date | May 2024 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Active, not recruiting |
Enrollment | 50 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 (ßhCG) 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 |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Local orbital control (i.e. local control within the radiation field) | Local orbital event will be estimated using the Kaplan-Meier method. | Up to 2 years post-radiation | |
Secondary | Complete response rate | Response rate will be estimated along with 95% confidence intervals. | Up to 2 years | |
Secondary | Local regional control (i.e. local control within the ipsilateral orbit but outside of the radiation field) | Up to 2 years post-radiation therapy | ||
Secondary | Overall survival (OS) | OS will be estimated using the Kaplan-Meier method. | Up to 2 years | |
Secondary | Freedom from distant relapse rates | Up to 2 years | ||
Secondary | Incidence of acute and chronic ocular toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 | Toxicity data will be summarized by frequency tables. | Up to 2 years |
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