Actively Recruiting
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
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-17
375
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
T
The Leukemia and Lymphoma Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a very low dose of radiation therapy (VLDRT) is an effective treatment for people with follicular lymphoma (FL) or marginal zone lymphoma (MZL). This study compares VLDRT to the standard dose of radiation therapy to see if the low dose can control cancer in affected areas and prevent new lymphoma spots while causing fewer side effects. Radiation therapy uses intense energy beams to kill cancer cells, and standard doses may cause both short- and long-term side effects. Researchers aim to find out if using less radiation can reduce these side effects while still working against the cancer. Participants will be randomly assigned to receive either the very low dose radiation therapy of 4 Gy given in 1-2 daily treatments or the standard radiation dose of 24 Gy given in 12 treatments over consecutive business days. Both treatments target all initially involved cancer sites. About 12 weeks after treatment, participants will have repeat imaging and clinical evaluations to assess the cancer's response to therapy. During the study, participants will undergo imaging and clinical assessments at 12 weeks post-treatment to monitor cancer progression and response. The primary outcome measured is progression-free survival at 2 years, with radiographic response also evaluated at 6 months. The total duration of participation varies, with ongoing monitoring to compare the effectiveness and side effects of the two radiation dosing strategies. This study is led by Memorial Sloan Kettering Cancer Center and has no masking or blinding.
CONDITIONS
Brief Title
A Study of Reduced Dose Radiation Therapy for People With B-Cell Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with follicular lymphoma or marginal zone lymphoma according to WHO 5th Edition or ICC criteria
- Stage I or II disease with lymph nodes on the same side of the diaphragm
- Newly diagnosed or previously observed with no prior lymphoma-directed therapy
- For localized gastric MALT lymphoma, documented negative H. Pylori testing within 6 months before radiation
- Age 18 years or older at enrollment
- Able to start radiation therapy within 2 months of randomization
You will not qualify if you...
- Prior radiation to the treatment site(s)
- Follicular lymphoma grade 3B or follicular large B cell lymphoma
- Planned concurrent systemic therapy, including oral steroids
- Cutaneous-only indolent lymphoma
- Complete removal of all disease by surgery
- Tumor size 5 cm or larger in maximum diameter
- Any concurrent medical or psychiatric condition making participation inappropriate as judged by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 to 2 weeks depending on assigned treatment
Participants receive radiation therapy with either a very low dose (4 Gy in 1-2 consecutive daily fractions) or a standard dose (24 Gy in 12 consecutive daily fractions) to all initially involved sites of disease.
1 to 12 visits (in-person) depending on assigned radiation dose
Duration - Approximately 12 weeks after treatment
Participants undergo repeat imaging and clinical evaluation approximately 12 weeks after completing radiation therapy to assess response to treatment.
1 visit (in-person)
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
B
Brandon Imber, MD
J
Joachim Yahalom, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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