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NCT Number: NCT07029217

A Study of Reduced Dose Radiation Therapy for People With 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.

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Key information

Conditions

Follicular Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Marginal Zone Lymphoma Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiation (Standard)

Radiation

24 Gy in 12 fractions

Radiation (Very low dose)

Radiation

4 Gy in 1-2 consecutive daily fractions

Primary outcomes

  1. 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

Secondary outcomes

  1. radiographic response

    Time frame: 6 months

    using Lugano criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Brandon Imber, MD

CONTACT

[email protected]

631-212-6346

Joachim Yahalom, MD

CONTACT

646-608-2639

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • The Leukemia and Lymphoma Society

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 19, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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