Reduced dose radiation therapy for indolent non-Hodgkin lymphoma
MC230808 Reduced Dose Hypofractionated Radiotherapy (3Gy x 3 Fractions) for Indolent Non-Hodgkin Lymphoma (POSEIDON): A Multisite Phase 2 Randomized Trial
This study is testing if a lower dose of radiation therapy can safely treat people with indolent non-Hodgkin lymphoma while causing fewer side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Scottsdale, Arizona and 6 other locations) |
| Trial ID | NCT06386315 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the safety and effectiveness of reduced dose radiation therapy compared to standard dose radiation in patients with indolent non-Hodgkin lymphoma. The study aims to determine if a lower radiation dose can reduce acute toxicity while maintaining treatment efficacy. Participants will receive radiation in fewer fractions and will be monitored for side effects, quality of life, and treatment response. Additionally, biopsies and imaging studies will be conducted to explore correlations between biological markers and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed indolent B-cell lymphoma, regardless of disease stage.
Not a fit: Patients with aggressive forms of lymphoma or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more tolerable treatment options for patients with indolent non-Hodgkin lymphoma.
How similar studies have performed: Previous studies have indicated that indolent lymphomas are sensitive to radiation, suggesting that reduced dose approaches may be effective, although this specific methodology is being tested for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Histological confirmation of indolent B-cell lymphoma that can include any of the following: * Follicular lymphoma (grade 1 or 2 or 3A) * Marginal zone lymphoma (nodal or extranodal) * Follicle center lymphoma * Any stage disease * Initial, refractory, or relapsed disease. If relapse involves the site to be treated there must be evidence of disease progression * Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3 * Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only * Provide written informed consent * Ability to complete questionnaire(s) by themselves or with assistance * Willing to return to enrolling institution for follow-up visits (during the active monitoring phase of the study). Virtual visits can also be considered as an option for applicable items * Confirmation from radiation oncologist of suitability to participate in study Exclusion Criteria: * Any of the following: * Pregnant women * Nursing women * Women of childbearing potential who are unwilling to employ adequate contraception * T-cell lymphoma * Receiving treatment for small and chronic lymphocytic lymphoma * Grade 3B follicular lymphoma
Where this trial is running
Scottsdale, Arizona and 6 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
- Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota, United States (Recruiting)
- Mayo Clinic Health System - Mankato — Mankato, Minnesota, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
- Mayo Clinic Health System-Eau Claire Clinic — Eau Claire, Wisconsin, United States (Recruiting)
- Mayo Clinic Health System-Franciscan Healthcare — La Crosse, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Brad S. Hoppe, MD, MPH — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.