Testing a Lower Dose of Radiation for Slow-Growing B-Cell Lymphomas
Compares very low radiation with standard radiation in adults with follicular or marginal zone lymphoma.
Key facts
- Who runs it
- Memorial Sloan Kettering Cancer Center
- Where
- Basking Ridge, Commack, Harrison, Middletown, Montvale, New York, and Uniondale, United StatesSee the 7 sites
- Trial code
- Registry title
- A Study of Reduced Dose Radiation Therapy for People With B-Cell Lymphomas
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 375 people, planned
- Started
- 9 Jun 2025
- Expected to end
- Jun 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Radiation (Standard)
- Radiation (Very low dose)
- Record updated
- 26 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed early-stage follicular lymphoma or marginal zone lymphoma. It compares a very low dose of radiation with the standard dose.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Follicular lymphoma or marginal zone lymphoma, stage I or II (one nodal region, or two or more regions on the same side of the diaphragm).
- Earlier treatment
- No earlier treatment aimed at the lymphoma. People newly diagnosed or previously only watched can join. Radiation must be able to start within 2 months of randomization.
- Biomarker or test result
- For stomach MALT lymphoma, a negative H. Pylori test within 6 months before radiation is needed.
Main reasons for not taking part
- Earlier radiation to the site that needs treatment
- Follicular lymphoma grade 3B or follicular large B cell lymphoma
- Planned medicine treatment for the lymphoma at the same time, including oral steroids
- Lymphoma only in the skin
- Tumor 5 cm (2 in) or larger (does not apply to stomach MALT lymphoma)
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior radiation to site(s) needing treatment
- Patients planned to receive concurrent systemic therapy (including oral steroids) for their lymphoma
- 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
- Gross total resection of all disease
- Follicular lymphoma, grade 3B (ICC) or Follicular large B cell lymphoma (FLBL by WHO 5th edition criteria)
- 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
- Tumor size measuring ≥5 cm in maximum diameter on any modality diagnostic imaging (Note: This exclusion criterion is not applicable to patients diagnosed with gastric MALT lymphoma)
Where in United States
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking Ridge, United StatesContact: Brandon Imber, MDTaking people
- Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)Commack, United StatesContact: Brandon Imber, MDTaking people
- Memorial Sloan Kettering Westchester (All Protocol Activities)Harrison, United StatesContact: Brandon Imber, MDTaking people
- Memorial Sloan Kettering Monmouth (All Protocol Activities)Middletown, United StatesContact: Brandon Imber, MDTaking people
- Memorial Sloan Kettering Bergen (All Protocol Activities)Montvale, United StatesContact: Brandon Imber, MDTaking people
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, United StatesContact: Brandon Imber, MDTaking people
- Memorial Sloan Kettering Nassau (All Protocol Activities)Uniondale, United StatesContact: Brandon Imber, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Very low dose of RadiationExisting treatment, for comparison
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.
Treatment: Radiation (Very low dose)
- Standard dose of RadiationTreatment being tested
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.
Treatment: Radiation (Standard)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Prospective Phase III Study Comparing Standard Radiotherapy (24 Gy) With a PET REsponse-guided Very Low Dose (4 Gy) Staged Radiotherapy Strategy for Potentially Curable, Indolent B-cell Lymphomas
- Plain-language title
- Testing a Lower Dose of Radiation for Slow-Growing B-Cell LymphomasGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 26 October 2026