Reduced-dose radiation therapy for people with follicular or marginal zone lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with localized (stage I–II) follicular or marginal zone lymphoma will be assigned to receive either very low-dose radiation therapy (VLDRT) or the standard radiation dose to the involved sites. The study compares tumor control in the treated areas, the development of new lymphoma sites, and the frequency and severity of short- and long-term side effects between the two dose levels. Radiation is delivered directly to areas of known disease, with VLDRT using a substantially lower total dose than standard treatment. Outcomes will determine whether lower-dose radiation provides comparable disease control with reduced toxicity.

Why it matters

Who can join: the full rules

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 (Note: This exclusion criterion is not applicable to patients diagnosed with gastric MALT lymphoma)
* 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

Where it's running

• Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (All Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (All Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (All Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Brandon Imber, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Brandon Imber, MD
• Email: imberb@mskcc.org
• Phone: 631-212-6346

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.