NCT07029217RecruitingPhase 3
A Study of Reduced Dose Radiation Therapy for People With B-Cell Lymphomas
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
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 375 (estimated)
- First submitted
- 10 Jun 2025
- Start date
- 9 Jun 2025
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Follicular lymphoma
- NCT number
- NCT07029217
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 375
- From 9 Jun 2025 to the primary completion date, 30 Jun 2028
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Gross total resection of all disease
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (All Protocol Activities) Coordinator of this site? Confirm its status | Basking Ridge | United States | Recruiting |
| Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) Coordinator of this site? Confirm its status | Commack | United States | Recruiting |
| Memorial Sloan Kettering Westchester (All Protocol Activities) Coordinator of this site? Confirm its status | Harrison | United States | Recruiting |
| Memorial Sloan Kettering Monmouth (All Protocol Activities) Coordinator of this site? Confirm its status | Middletown | United States | Recruiting |
| Memorial Sloan Kettering Bergen (All Protocol Activities) Coordinator of this site? Confirm its status | Montvale | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan Kettering Nassau (All Protocol Activities) Coordinator of this site? Confirm its status | Uniondale | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.