A Study of Reduced Dose Radiation Therapy for People With B-Cell Lymphomas
NCT ID: NCT07029217
Last Updated: 2025-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
375 participants
INTERVENTIONAL
2025-06-09
2028-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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 (Very low dose)
4 Gy in 1-2 consecutive daily fractions
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 (Standard)
24 Gy in 12 fractions
Interventions
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Radiation (Standard)
24 Gy in 12 fractions
Radiation (Very low dose)
4 Gy in 1-2 consecutive daily fractions
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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The Leukemia and Lymphoma Society
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Brandon Imber, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States
Countries
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Central Contacts
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Joachim Yahalom, MD
Role: CONTACT
Facility Contacts
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Brandon Imber, MD
Role: primary
Brandon Imber, MD
Role: primary
Brandon Imber, MD
Role: primary
Brandon Imber, MD
Role: primary
Brandon Imber, MD
Role: primary
Brandon Imber, MD
Role: primary
Brandon Imber, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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25-089
Identifier Type: -
Identifier Source: org_study_id
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