NCT07029217 A Study of Reduced Dose Radiation Therapy for People With B-Cell Lymphomas
| NCT ID | NCT07029217 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Follicular Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 375 participants |
| Start Date | 2025-06-09 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 375 participants in total. It began in 2025-06-09 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 * 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 Criteria: * 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
Contact & Investigator
Brandon Imber, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT07029217 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Follicular Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07029217 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 375 participants.
Is NCT07029217 currently recruiting?
Yes, NCT07029217 is actively recruiting participants. Contact the research team at imberb@mskcc.org for enrollment information.
Where is the NCT07029217 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT07029217 clinical trial?
NCT07029217 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Brandon Imber, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 375 participants.