RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2025-06-09
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07029217

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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:
  2. * Follicular lymphoma
  3. * WHO 5th Edition
  4. * Classic follicular lymphoma (cFL)
  5. * Follicular lymphoma with uncommon features (uFL)
  6. * Pediatric type follicular lymphoma
  7. * Duodenal type follicular lymphoma
  8. * ICC
  9. * Follicular lymphoma, grades 1-2 or 3A
  10. * BCL2 rearrangement negative, CD23 positive follicle center lymphoma
  11. * Pediatric type follicular lymphoma
  12. * Duodenal type follicular lymphoma
  13. * Marginal zone lymphoma
  14. * WHO 5th Edition and ICC
  15. * Nodal marginal zone lymphoma
  16. * Pediatric nodal marginal zone lymphoma
  17. * Extranodal marginal zone lymphoma of mucosa associated lymphoid tissue (MALT)
  18. * 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)
  19. * Patients should be newly diagnosed or previously observed with no prior lymphoma-directed therapy
  20. * 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
  21. * Age at the time of enrollment of ≥18 years
  22. * Patients must be able to start radiation within 2 months from time of randomization
  1. * Prior radiation to site(s) needing treatment
  2. * Follicular lymphoma, grade 3B (ICC) or Follicular large B cell lymphoma (FLBL by WHO 5th edition criteria)
  3. * Patients planned to receive concurrent systemic therapy (including oral steroids) for their lymphoma
  4. * 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
  5. * Gross total resection of all disease
  6. * Tumor size measuring ≥5 cm in maximum diameter on any modality diagnostic imaging
  7. * 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

Contacts and Locations

Study Contact

Brandon Imber, MD
CONTACT
631-212-6346
imberb@mskcc.org
Joachim Yahalom, MD
CONTACT
646-608-2639

Principal Investigator

Brandon Imber, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Brandon Imber, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

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 Registration Dates

Study Start Date2025-06-09
Study Completion Date2028-06

Study Record Updates

Study Start Date2025-06-09
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • Stage I-II
  • Radiotherapy
  • 25-089

Additional Relevant MeSH Terms

  • Follicular Lymphoma
  • Marginal Zone Lymphoma