A Study of Reduced Dose Radiation Therapy for People With B-Cell Lymphomas

February 12, 2026 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

375

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Joachim Yahalom, MD
  • Phone Number: 646-608-2639

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
        • Contact:
          • Brandon Imber, MD
          • Phone Number: 631-212-6346
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (All Protocol Activities)
        • Contact:
          • Brandon Imber, MD
          • Phone Number: 631-212-6346
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (All Protocol Activities)
        • Contact:
          • Brandon Imber, MD
          • Phone Number: 631-212-6346
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
        • Contact:
          • Brandon Imber, MD
          • Phone Number: 631-212-6346
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (All Protocol Activities)
        • Contact:
          • Brandon Imber, MD
          • Phone Number: 631-212-6346
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All protocol activities)
        • Contact:
          • Brandon Imber, MD
          • Phone Number: 631-212-6346
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (All protocol activities)
        • Contact:
          • Brandon Imber, MD
          • Phone Number: 631-212-6346

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Very low dose of Radiation
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)
4 Gy in 1-2 consecutive daily fractions
Experimental: Standard dose of Radiation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: 2 years

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
radiographic response
Time Frame: 6 months
using Lugano criteria
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

The Leukemia and Lymphoma Society

Investigators

  • Principal Investigator: Brandon Imber, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

June 10, 2025

First Submitted That Met QC Criteria

June 17, 2025

First Posted (Actual)

June 19, 2025

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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