A Phase 3 interventional study of Radiation (Standard) and Radiation (Very low dose) in Follicular Lymphoma and Marginal Zone Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 3, Interventional, and Treatment
The researchers are doing this study to find out whether a very low dose of radiation therapy (VLDRT) is an effective treatment for people with follicular lymphoma (FL) or marginal zone lymphoma (MZL) and works as well as the standard dose of radiation therapy. The researchers will see if VLDRT works against cancer in the area that is currently affected by cancer and if the therapy prevents new spots of lymphoma from developing. The researchers will also compare VLDRT with the standard dose of radiation therapy to see if VLDRT causes fewer side effects.
Radiation therapy uses beams of intense energy to kill cancer cells. Standard doses of radiation therapy can cause short- and long-term side effects. Researchers think VLDRT may be as effective as standard doses, and, because VLDRT uses less radiation, researchers think VLDRT may cause fewer side effects than standard doses.
931 studies on the registry are indexed under Lymphoma, Follicular; 237 are open to participants now.
This study's planned enrollment of 375 is above the median of 48 across 797 interventional studies indexed under Lymphoma, Follicular.
Browse Lymphoma, Follicular studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: (Arms 1\&2)
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
ICC
Marginal zone lymphoma
WHO 5th Edition and ICC
Exclusion Criteria:
Patients will receive a total of 4 Gy in 1-2 consecutive daily fractions comprehensively to all initially involved sites of disease. At 12 weeks (+/- 4 weeks) post VLDRT, the patient will undergo repeat imaging and clinical evaluation.
Radiation: Radiation (Very low dose)
Patients will receive a total of 24 Gy in 12 fractions comprehensively to all initially involved sites of disease over 12 consecutive business days. At 12 weeks (+/- 4 weeks) post VLDRT, the patient will undergo repeat imaging and clinical evaluation.
Radiation: Radiation (Standard)
24 Gy in 12 fractions
4 Gy in 1-2 consecutive daily fractions
progression-free survival
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
Time frame: 2 years
radiographic response
using Lugano criteria
Time frame: 6 months
Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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