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
1 other identifier
interventional
375
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2025
Typical duration for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 9, 2025
CompletedFirst Submitted
Initial submission to the registry
June 10, 2025
CompletedFirst Posted
Study publicly available on registry
June 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
February 17, 2026
February 1, 2026
3 years
June 10, 2025
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 years
Secondary Outcomes (1)
radiographic response
6 months
Study Arms (2)
Very low dose of Radiation
ACTIVE COMPARATORPatients 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.
Standard dose of Radiation
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +7 more criteria
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brandon Imber, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2025
First Posted
June 19, 2025
Study Start
June 9, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
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.