Reduced Dose Radiation Therapy for B-Cell Lymphomas

This study is investigating whether a very low dose of radiation therapy (4 Gy in 1-2 daily treatments) is as effective as the standard dose of radiation therapy (24 Gy in 12 treatments) for people with follicular lymphoma or marginal zone lymphoma. Researchers want to see if the very low dose works well against the cancer and prevents new lymphoma spots, while also causing fewer side effects. You may be eligible if you are 18 years or older and have been diagnosed with follicular lymphoma or marginal zone lymphoma. The study aims to enroll 375 participants and will measure how long people live without their cancer progressing over two years. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 375 participants. It compares two different radiation therapy doses for B-cell lymphomas.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure progression-free survival at 2 years.

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NCT07029217

A Study of Reduced Dose Radiation Therapy for People With B-Cell Lymphomas

Recruiting
PHASE3Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~375 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:Radiation (Standard)Radiation (Very low dose)

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
progression-free survival
Measured over 2 years
Follicular Lymphoma
Marginal Zone Lymphoma
7 sites across 2 states
New York4
New Jersey3
  • Brandon Imber, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

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Eligibility criteria

Inclusion

Patients must be diagnosed with a follicular lymphoma or marginal zone lymphoma. Of note, there are now two widely-utilized pathology classification criteria used for mature B-cell lymphomas, the World Health Organization (WHO) 5th Edition Classification of Lymphoid Neoplasms and the International Consensus Classification (ICC) of Mature Lymphoid Neoplasms. Either criteria is acceptable and for the purposes of this protocol, the following diagnoses are included:
Follicular lymphoma
WHO 5th Edition
Classic follicular lymphoma (cFL)
Follicular lymphoma with uncommon features (uFL)
Pediatric type follicular lymphoma
Duodenal type follicular lymphoma
ICC
Follicular lymphoma, grades 1-2 or 3A
BCL2 rearrangement negative, CD23 positive follicle center lymphoma
Pediatric type follicular lymphoma
Duodenal type follicular lymphoma
Marginal zone lymphoma
WHO 5th Edition and ICC
Nodal marginal zone lymphoma
Pediatric nodal marginal zone lymphoma
Extranodal marginal zone lymphoma of mucosa associated lymphoid tissue (MALT)
Patients must have stage I or II disease (with stage I defined as involvement of one nodal region and stage II as two or more nodal regions involved on the same side of the diaphragm)
Patients should be newly diagnosed or previously observed with no prior lymphoma-directed therapy
If the patient is referred for localized gastric MALT lymphoma, there should be documented negative H. Pylori testing within 6 months prior to proposed radiotherapy
Age at the time of enrollment of ≥18 years
Patients must be able to start radiation within 2 months from time of randomization

Exclusion

Prior radiation to site(s) needing treatment
Follicular lymphoma, grade 3B (ICC) or Follicular large B cell lymphoma (FLBL by WHO 5th edition criteria)
Patients planned to receive concurrent systemic therapy (including oral steroids) for their lymphoma
Patient has cutaneous only iNHL defined as primary cutaneous B-cell lymphoma, primary cutaneous follicle center lymphoma, cutaneous marginal zone lymphoma or unspecified indolent lymphoma of the skin
Gross total resection of all disease
Tumor size measuring ≥5 cm in maximum diameter on any modality diagnostic imaging
Patients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study
  • progression-free survival2 years

    Progression will be defined as either PD as per Lugano criteria (either treated or non-treated lesions) OR * Receipt of any additional radiotherapy for lymphoma to an initially involved site outside of the protocol mandated treatment OR * Death from any cause