Low-Dose Radiation for Marginal Zone Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen by Jillian Gunther

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Other lymphoma, Scleroderma, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

To learn if response-adapted, ultra-low dose radiation therapy can help to control MZL. This means participates first receive lower does of radiation therapy and then, based on how the disease responds, may receive higher doses after that.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that prior systemic therapy is allowed as long as it was given before the most recent disease assessment.

What data supports the effectiveness of the treatment Ultra Low Dose 4 Gy Radiation for Marginal Zone Lymphoma?

Research shows that very-low-dose radiation therapy (4 Gy) is effective for indolent B-cell lymphomas, including marginal zone lymphoma, with a 90% overall response rate and 68% achieving complete response. This suggests that low-dose radiation can be a successful treatment option for these types of lymphomas. ^{1 2 3 4 5}

Is low-dose radiation therapy safe for treating marginal zone lymphoma?

Low-dose radiation therapy, such as 4 Gy, has been used safely in treating indolent lymphomas like marginal zone lymphoma, with reduced side effects compared to higher doses. Studies show high response rates and minimal significant late toxicity, making it a generally safe option for patients. ^{1 3 4 5 6}

How is the Ultra Low Dose 4 Gy Radiation treatment different from other treatments for marginal zone lymphoma?

The Ultra Low Dose 4 Gy Radiation treatment is unique because it uses a much lower radiation dose compared to the standard 24 Gy, reducing side effects and treatment time while still achieving high response rates in patients with marginal zone lymphoma. ^{1 2 4 5 6}

Research Team

Jillian Gunther

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with stage I-II marginal zone lymphoma who can sign consent. It's open to those who've had prior treatments but still show signs of the disease, and not planning systemic therapy before follow-up. Participants must use birth control if they can have children, and cannot join if they're pregnant or have certain psychiatric conditions that affect compliance.

Inclusion Criteria

I am 18 years old or older.

I am not scheduled for any drug treatments before my first check-up after radiation.

I have had previous treatments for my condition, regardless of type or amount.

Exclusion Criteria

Patients living outside the US

I have had a condition where my lymphocytes grow abnormally.

I am currently being treated for active scleroderma.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive ultra-low dose 4 Gy radiation therapy over 1-2 days

1-2 days

Response Evaluation

Participants' response to the initial radiation dose is evaluated to determine if additional radiation is needed

2-4 weeks

Additional Radiation (if needed)

Participants may receive an additional 12 Gy of radiation based on their response to the initial treatment

1-2 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of distant recurrence and in-field relapse at 24 months

24 months

Treatment Details

Interventions

• Ultra Low Dose 4 Gy Radiation (Radiation)

Trial Overview The study tests ultra-low dose radiation therapy as a primary treatment for marginal zone lymphoma. Patients start with low doses which may be increased based on their response to the initial treatment, aiming to control the disease with minimal exposure.

Participant Groups

Group I: Ultra Low Dose 4 Gy Radiation Experimental Treatment 1 Intervention

Participants will receive the ultra-low doses of radiation therapy over 1-2 days

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

Findings from Research

In a study of 250 patients with follicular or marginal zone lymphoma, very-low-dose radiotherapy (VLDRT) of 4 Gy resulted in a high overall response rate of 90%, with 68% achieving a complete response, demonstrating its efficacy in treating localized indolent non-Hodgkin lymphomas.

The 2-year cumulative incidence of local progression was 25% overall, but only 9% for patients receiving VLDRT as first-line treatment for potentially curable disease, suggesting that VLDRT is a safe and effective option that may reduce treatment duration and toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Excellent response to very-low-dose radiation (4 Gy) for indolent B-cell lymphomas: is 4 Gy suitable for curable patients? Imber, BS., Chau, KW., Lee, J., et al.[2022]

In a study of 13 patients with primary BALT lymphoma treated with radiotherapy, there was a 100% response rate, with 67% achieving complete response, indicating that radiotherapy is highly effective for this rare cancer.

Very low-dose radiotherapy (4 Gy) resulted in a 60% complete response rate, while full-dose radiotherapy (24-36 Gy) had an 80% complete response rate, demonstrating that even lower doses can be effective and that the treatment is generally safe with minimal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Very low-dose radiotherapy for extranodal marginal zone lymphoma of bronchus-associated lymphoid tissue. Freret, ME., Tringale, KR., Boe, L., et al.[2023]

Localized low-dose radiotherapy (LDRT) has shown a 55% complete response rate in treating chemoresistant indolent non-Hodgkin's lymphomas, with effective doses as low as 4 Gy given in two fractions.

LDRT induces apoptosis in follicular lymphoma cells, which triggers an immune response involving macrophages and dendritic cells, suggesting a potential mechanism for its efficacy and a promising avenue for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Localized low-dose radiotherapy for follicular lymphoma: history, clinical results, mechanisms of action, and future outlooks. Ganem, G., Cartron, G., Girinsky, T., et al.[2010]

In a study of 7 patients with low-grade orbital lymphomas treated with ultra-low dose radiotherapy (ULDRT), there was a remarkable local control rate of 100%, with 71% achieving a complete response after a median follow-up of 22 months.

The treatment was associated with minimal toxicity, with only mild side effects like dry eye and pruritus reported, making ULDRT a promising option for managing indolent orbital lymphomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-low dose radiotherapy in the management of low-grade orbital lymphomas. de Castro, B., Peixeiro, RP., Mariz, JM., et al.[2022]

In a study involving 10 patients with localized pulmonary MALT lymphoma, treatment with very low radiation doses (2 × 2 Gy) delivered exclusively to tumor sites resulted in a 60% complete remission rate within the first 2 months.

The 5-year progression-free survival rate was 87.5%, indicating that this approach is not only effective but also safe, as all patients remained alive with no local progression observed during the median follow-up of 56 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose radiation treatment in pulmonary mucosa-associated lymphoid tissue lymphoma: a plausible approach? A single-institution experience in 10 patients. Girinsky, T., Paumier, A., Ferme, C., et al.[2022]

In a study of 24 patients with orbital marginal zone lymphoma treated with 24-25 Gy of radiotherapy, all patients achieved a complete response, demonstrating the high efficacy of this treatment.

The study reported excellent long-term outcomes, with 100% overall survival and 90% freedom from progression at 2 years, while noting that aside from cataract formation, there was minimal late toxicity associated with the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of low dose radiotherapy for primary orbital marginal zone lymphoma. Tran, KH., Campbell, BA., Fua, T., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Excellent response to very-low-dose radiation (4 Gy) for indolent B-cell lymphomas: is 4 Gy suitable for curable patients? [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Very low-dose radiotherapy for extranodal marginal zone lymphoma of bronchus-associated lymphoid tissue. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Localized low-dose radiotherapy for follicular lymphoma: history, clinical results, mechanisms of action, and future outlooks. [2010]

4. Poland pubmed.ncbi.nlm.nih.gov

Ultra-low dose radiotherapy in the management of low-grade orbital lymphomas. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Low-dose radiation treatment in pulmonary mucosa-associated lymphoid tissue lymphoma: a plausible approach? A single-institution experience in 10 patients. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy of low dose radiotherapy for primary orbital marginal zone lymphoma. [2019]