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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07029217
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 9, 2025
Status verified
Feb 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
375 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Experimental: 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.

Primary Outcome Measure

progression-free survival [ Time Frame: 2 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking RidgeNew Jersey07920
Brandon Imber, MD
631-212-6346
Memorial Sloan Kettering Monmouth (All Protocol Activities)MiddletownNew Jersey07748
Brandon Imber, MD
631-212-6346
Memorial Sloan Kettering Bergen (All Protocol Activities)MontvaleNew Jersey07645
Brandon Imber, MD
631-212-6346
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)CommackNew York11725
Brandon Imber, MD
631-212-6346
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604
Brandon Imber, MD
631-212-6346
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Brandon Imber, MD
631-212-6346
Memorial Sloan Kettering Nassau (All Protocol Activities)UniondaleNew York11553
Brandon Imber, MD
631-212-6346

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Memorial Sloan Kettering Basking Ridge (All Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (All Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (All Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk - Commack (All Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (All Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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