Recruiting

Phase 2

Reduced Dose RadiotherapyReduced Dose Radiotherapy for the Treatment of Indolent Non-Hodgkin Lymphoma

Sponsor:

Mayo Clinic

Code:

NCT06386315

Conditions

Indolent B-Cell Non-Hodgkin Lymphoma

Recurrent Indolent B-Cell Non-Hodgkin Lymphoma

Refractory Indolent B-Cell Non-Hodgkin Lymphoma

Recurrent Indolent Non-Hodgkin Lymphoma

Refractory Indolent Non-Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography

Endoscopic Procedure

Involved-site Radiation Therapy (3 Fractions)

Involved-site Radiation Therapy (12 Fractions)

Positron Emission Tomography

Study Details

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.

Conditions

Indolent B-Cell Non-Hodgkin Lymphoma

Recurrent Indolent B-Cell Non-Hodgkin Lymphoma

Refractory Indolent B-Cell Non-Hodgkin Lymphoma

Recurrent Indolent Non-Hodgkin Lymphoma

Refractory Indolent Non-Hodgkin Lymphoma

Study ID

NCT06386315

Start date

May 15, 2024

Status verified date

Apr, 2026

Completion date

May 30, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

112 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ARM 1 (reduced dose ISRT)

Patients undergo reduced dose ISRT once daily (excluding weekends): 9 Gy delivered in 3 treatment fractions or 8 Gy in 2 fractions. At physician discretion, patients may receive 10 Gy in 5 fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up.

active comparator: ARM 2 (SOC ISRT)

Patients undergo standard of care (SOC) radiation therapy once daily (excluding weekends): 24 Gy in 12 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up.

Interventions

Computed Tomography

Undergo CT or PET/CT

Endoscopic Procedure

Undergo endoscopy

Involved-site Radiation Therapy (3 Fractions)

Undergo ISRT in 3 fractions

Involved-site Radiation Therapy (12 Fractions)

Undergo ISRT in 12 fractions

Positron Emission Tomography

Undergo PET/CT

Questionnaire Administration

Ancillary studies

Primary outcome measure

Incidence of grade 2 or higher acute adverse events (AEs) [ Time Frame: Up to 14 days after radiation treatment ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

William G. Rule, MD

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Brad S. Hoppe, MD, MPH

Mayo Clinic Health System in Albert Lea

Recruiting

Albert Lea, Minnesota, United States, 56007

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

John Yeakel, MD

Mayo Clinic Health System - Mankato

Recruiting

Mankato, Minnesota, United States, 56001

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Jason T. Hayes, MD

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Scott C. Lester, MD

Mayo Clinic Health System-Eau Claire Clinic

Recruiting

Eau Claire, Wisconsin, United States, 54701

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Now Bahar Alam, MD

Mayo Clinic Health System-Franciscan Healthcare

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Abigail L. Stockham, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-22.