Menu
Recruiting NCT07029217

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

Phase III Interventional Follicular Lymphoma Marginal Zone Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiation (Standard), Radiation (Very low dose).
Who it may be relevant to
Registry conditions: Follicular Lymphoma, Marginal Zone Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Radiation Radiation (Standard)
    24 Gy in 12 fractions
  • Radiation Radiation (Very low dose)
    4 Gy in 1-2 consecutive daily fractions

Primary outcome measures

  • progression-free survival [Time frame: 2 years]
Secondary outcome measures (1)
  • radiographic response [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale

Identifiers

NCT: NCT07029217 · 25-089

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗