NCT06386315 Reduced Dose Radiotherapy for the Treatment of Indolent Non-Hodgkin Lymphoma
| NCT ID | NCT06386315 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | Indolent B-Cell Non-Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2024-05-15 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 112 participants in total. It began in 2024-05-15 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This phase II trial compares the safety, side effects and effectiveness of reduced dose radiation therapy to standard of care dose radiation in treating patients with indolent non-Hodgkin lymphoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard of care radiation treatment for indolent non-Hodgkin lymphoma is usually delivered in 12 treatments. Studies have shown indolent lymphoma to be sensitive to radiation treatment, however, larger doses have higher rates of toxicities. A reduced radiation dose may be safe, tolerable and/or effective compared to standard of care radiation dose in treating patients with indolent non-Hodgkin lymphoma.
Eligibility 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
Contact & Investigator
Brad S. Hoppe, MD, MPH
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06386315 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Indolent B-Cell Non-Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06386315 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06386315 currently recruiting?
Yes, NCT06386315 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT06386315 trial being conducted?
This trial is being conducted at Scottsdale, United States, Jacksonville, United States, Albert Lea, United States, Mankato, United States and 3 additional locations.
Who is sponsoring the NCT06386315 clinical trial?
NCT06386315 is sponsored by Mayo Clinic. The principal investigator is Brad S. Hoppe, MD, MPH at Mayo Clinic. The trial plans to enroll 112 participants.