Reduced Dose Radiation Therapy for Follicular Lymphoma

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Oral steroids

Disqualifiers: Prior radiation, Tumor size ≥5 cm, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

375 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of a very low dose of radiation therapy (VLDRT) to treat follicular lymphoma and marginal zone lymphoma. The goal is to determine if VLDRT can effectively target cancer and prevent new growths while causing fewer side effects than the standard radiation dose. Individuals diagnosed with stage I or II follicular or marginal zone lymphoma, who have not yet received any lymphoma-directed therapy, might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude patients who are planned to receive other systemic therapy (like oral steroids) for their lymphoma. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that very low dose radiation therapy (VLDRT) is generally well-tolerated by patients with certain types of lymphoma. Studies indicate that VLDRT, which uses a total of 4 Gy of radiation, has a high success rate. For example, one study found a 90% overall response rate in patients with slow-growing B-cell lymphomas. Additionally, VLDRT demonstrated excellent results in specific cases, such as lung MALT lymphoma, where patients achieved complete local control without needing further treatment.

Compared to the standard radiation dose of 24 Gy, VLDRT may cause fewer side effects due to its lower radiation use. This reduction can potentially lead to fewer short- and long-term side effects, making it a safer option for some patients. Overall, evidence suggests that VLDRT is a promising and safer alternative, though more research is needed to fully understand its long-term safety. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for lymphoma?

Researchers are excited about the reduced dose radiation therapy for follicular lymphoma because it offers a potentially safer and more convenient option for patients. Unlike the standard treatment, which involves a total of 24 Gy over several weeks, this approach uses a very low dose of only 4 Gy delivered in just 1-2 days. This significant reduction in radiation exposure could minimize side effects and improve the patient's quality of life while still effectively targeting the cancer. Additionally, the shorter treatment duration means less time spent in the hospital, which is a huge advantage for patients.

What evidence suggests that this trial's treatments could be effective for follicular lymphoma?

Research has shown that very low dose radiation therapy (VLDRT) holds promise for treating follicular lymphoma. In this trial, participants will receive either a very low dose or a standard dose of radiation. Studies indicate that administering two doses of VLDRT at 2 Gy results in a 90% overall response rate in various slow-growing B-cell lymphomas. This suggests that most patients experience a significant reduction in cancer with VLDRT. Additionally, VLDRT has proven effective for grade 3A follicular lymphoma, offering a shorter treatment duration and potentially fewer side effects. Overall, VLDRT appears to be a strong option for effectively managing these lymphomas. ^{1 4 6 7 8}

Who Is on the Research Team?

Brandon Imber, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with B-cell lymphomas, specifically those diagnosed with follicular lymphoma or marginal zone lymphoma. The study aims to include participants who can potentially benefit from radiation therapy.

Inclusion Criteria

I can start radiation treatment within 2 months after being chosen for the trial.

My cancer is in the early stages (stage I or II).

I have gastric MALT lymphoma and tested negative for H. Pylori within the last 6 months.

Exclusion Criteria

I have had radiation therapy on the areas that now need treatment.

My tumor is at least 5 cm wide.

I am scheduled for treatment that includes medication for my lymphoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive either a very low dose (4 Gy) or standard dose (24 Gy) of radiation therapy

1-2 weeks

1-2 visits (in-person)

Evaluation

Repeat imaging and clinical evaluation to assess response to radiation therapy

12 weeks

1 visit (in-person)

Follow-up

Participants are monitored for progression-free survival and radiographic response

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Very low dose Radiation Therapy

Trial Overview The study is testing the effectiveness of a very low dose of radiation therapy (VLDRT) compared to the standard dose in treating cancer and preventing new spots of lymphoma. It's designed to see if VLDRT can be as effective but cause fewer side effects.

How Is the Trial Designed?

Group I: Standard dose of Radiation Experimental Treatment 1 Intervention

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.

Group II: Very low dose of Radiation Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

The Leukemia and Lymphoma Society

Collaborator

Trials

87

Recruited

26,200+

Citations

1. ashpublications.org ashpublications.org/bloodadvances/article/5/20/4185/476935/Excellent-response-to-very-low-dose-radiation-4-Gy

Excellent response to very-low-dose radiation (4 Gy) for ... Two doses of VLDRT at 2 Gy are associated with an impressive overall response rate of 90% across diverse indolent B-cell lymphomas.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8945632/

Excellent response to very-low-dose radiation (4 Gy) for ... Two doses of VLDRT at 2 Gy are associated with an impressive overall response rate of 90% across diverse indolent B-cell lymphomas.

3. mskcc.org mskcc.org/clinical-updates/very-low-dose-radiotherapy-effective-grade-3a-follicular-lymphoma

Very Low-Dose Radiotherapy Effective for Grade 3A ... Very low-dose radiotherapy (VLDRT) is effective for treating grade 3A follicular lymphoma and provides patients with a shorter treatment course and fewer side ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2773066224000020

Treatment of follicular lymphoma with a focus on radiotherapy For advanced stage, median overall survival (OS) was 12.9 years, 5-year and 10-year OS were 77% and 63%, and 5-year and 10-yr PFS were 57% and 40% respectively.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07029217

NCT07029217 | A Study of Reduced Dose Radiation ... 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 ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1470204520306860

4 Gy versus 24 Gy radiotherapy for follicular and marginal ... Our findings at 5 years show that the optimal radiotherapy dose for indolent lymphoma is 24 Gy in 12 fractions when durable local control is the aim of ...

7. advancesradonc.org advancesradonc.org/article/S2452-1094(24)00211-2/fulltext

Ultra–Low-Dose Radiation for Extranodal Marginal Zone ... Conclusions. Patients with lung MALT experienced excellent outcomes following RA-ULDRT, with 100% LC after 4 Gy and no patients requiring ...

8. onclive.com onclive.com/view/very-low-dose-radiation-therapy-demonstrates-efficacy-in-indolent-non-hodgkin-lymphoma

Very Low Dose Radiation Therapy Demonstrates Efficacy ... Previous research has indicated that 24 Gy for 12 treatments was effective for disease control in patients with localized follicular lymphoma. 2 ...