Radiation Therapy for Lymphoma

Overseen By Peter Riedell, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: Statins

Disqualifiers: Indolent lymphoma, Cardiovascular disease, Seizure disorder, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether shorter courses of radiation therapy can safely treat relapsed or refractory Hodgkin and Non-Hodgkin lymphoma. Typically, radiation treatment lasts 5-6 weeks. This study tests if a shorter duration can be effective and safe, aiming to determine the safest reduced dose. Suitable participants include those with confirmed relapsed or refractory Hodgkin or Non-Hodgkin lymphoma who have already tried other standard treatments. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could lead to more convenient treatment options.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot receive chemotherapy, targeted therapy, or anti-cancer monoclonal antibodies during the trial. You may continue using steroids and certain hormone treatments. If you are taking statins, you may need to stop unless you have been on them for over 3 months without issues.

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

Research has shown that radiation therapy for lymphoma typically uses lower doses than those for other cancers, potentially making it safer for patients. Studies have found that radiation therapy for certain types of lymphoma leads to high success rates and favorable survival outcomes.

In some studies, patients who received radiation experienced good survival rates and few serious side effects, indicating that radiation therapy is generally well-tolerated. One study on proton beam therapy for Hodgkin lymphoma showed high survival rates and low cancer progression over time. These findings suggest that radiation therapy is a safe treatment option for many lymphoma patients.

Radiation therapy is already a common treatment for lymphoma, and its safety is well-established. Most patients tolerate it well, although some side effects, such as tiredness and skin changes, can occur but are often manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this radiation therapy for lymphoma because it uses a linear accelerator to deliver high-energy radiation through an IV, a method not commonly used in standard treatments. This targeted method allows for precise delivery to cancerous lesions while minimizing exposure to surrounding healthy tissue. Additionally, the treatment duration is flexible, ranging from a quick one-week course to a three-week regimen, depending on the dose group, potentially offering more convenience and tailored care compared to traditional radiation treatments.

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

Research has shown that radiation therapy effectively treats many types of lymphoma, including Hodgkin and Non-Hodgkin. In one study, 62.3% of patients did not experience treatment failure five years after receiving only radiation. Another study found that patients who fully responded to radiation had a 5-year overall survival rate of 78.6%. Radiation therapy has proven effective for various stages and forms of lymphoma. This trial will explore different dose levels of radiation therapy to determine if shorter treatments can be safe and effective, potentially offering the same benefits in less time. ^{2 6 7 8 9}

Who Is on the Research Team?

Yasmin Hasan, MD

Principal Investigator

University of Chicago - Comprehensive Cancer Center

Are You a Good Fit for This Trial?

Adults over 18 with relapsed/refractory Hodgkin/non-Hodgkin lymphoma, who've tried standard treatments without success. They must have measurable disease and be in relatively good health (ECOG ≤ 2). Women of childbearing age need a negative pregnancy test and agree to contraception; men must also follow contraceptive guidelines.

Inclusion Criteria

Participants who are WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) and up to 5 months post last dose of study drug(s).

I am not currently breastfeeding.

I am a male who does not produce sperm, so I don't need birth control measures.

Exclusion Criteria

I do not have active Hepatitis B or C.

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

I need daily oxygen therapy due to heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive high-energy radiation to a focused area of the body using a linear accelerator. The treatment duration varies from 3 treatments in less than 1 week to 14 treatments over 3 weeks, depending on the dose group.

1-3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments for adverse events and overall survival.

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Radiation

Trial Overview The trial is testing different doses of radiation therapy to find the safest short-duration treatment for lymphoma. Participants will receive one of five levels of radiation intensity to determine if less exposure is effective and safe compared to the typical 5-6 week regimen.

How Is the Trial Designed?

Group I: Dose-Finding Group 4 - Dose Level 4 Experimental Treatment 1 Intervention

High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment. The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned. Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).

Group II: Dose-Finding Group 3 - Dose Level 3 Experimental Treatment 1 Intervention

High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment. The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned. Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).

Group III: Dose-Finding Group 2 - Dose Level 2 Experimental Treatment 1 Intervention

High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment. The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned. Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).

Group IV: Dose-Finding Group 1 - Dose Level 1 Experimental Treatment 1 Intervention

High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment. The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned. Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).

Group V: Dose-Finding Group 0 - Dose Level 0 Experimental Treatment 1 Intervention

High-energy radiation will be delivered to a focused area of your body using a treatment machine called a linear accelerator. Radiation will be delivered through an IV. A mold will also be customized to fit your body, so you don't move during the radiation process. The actual time on the radiation treatment machine will be 30-60 minutes. The mold will be removed after the treatment. The longest possible treatment will be 14 radiation treatments over a course of 3 weeks. The shortest possible treatment will be 3 treatments in duration or less than 1 week. The amount of time required for radiation treatment depends on the dose group your are assigned. Participants will receive radiation to at least 1 but no more than 5 lesions (areas of body with cancer).

Radiation is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation Therapy for:

• Cancer treatment
• HPV-positive throat cancer
• Various types of tumors

Approved in United States as Radiation Therapy for:

• Cancer treatment
• HPV-positive throat cancer
• Various types of tumors

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• HPV-positive throat cancer
• Various types of tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• HPV-positive throat cancer
• Various types of tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• HPV-positive throat cancer
• Various types of tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• HPV-positive throat cancer
• Various types of tumors

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38631539/

Involved-site Radiation Therapy is Equally Effective and ... Combined modality treatment with chemotherapy followed by consolidation radiation therapy (RT) provides excellent outcomes for patients with early-stage ...

2. redjournal.org redjournal.org/article/S0360-3016(24)00514-5/fulltext

Involved-site Radiation Therapy is Equally Effective and ... Kaplan-Meier estimates of 4-year progression-free survival were 96.8% (95% CI, 91.6%-98.8%) in the IFRT group and 95.4% (95% CI, 89.9%-97.9%; HR ...

3. nature.com nature.com/articles/s41408-022-00620-w

Clinical outcomes with use of radiation therapy and risk ... The survival after RT alone from the current study is again excellent, with 62.3% of patients free from treatment failure 5 years after ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2452109424002100

Treatment Outcomes and Prognostic Factors of ... After treatment, the 5-year overall survival rate was 78.6% in complete response patients versus 44.9% in noncomplete response patients (P = .003). For patients ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6536292/

INFRADIAPHRAGMAL RADIOTHERAPY IN PATIENTS ... Radiation has been shown to be effective in the treatment of all stages and forms of lymphoma. Study data are still mostly derived from patients that received ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8553178/

Outcome-based multiobjective optimization of lymphoma ... The radiation doses needed for curative treatment of lymphomas are significantly lower than those generally needed for most solid tumors. However, RT, even at ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO-24-01373

Omission of Radiotherapy in Primary Mediastinal B-Cell ... This study, the largest randomized trial of radiotherapy in PMBCL, demonstrated favorable outcomes in patients achieving CMR with no survival ...

8. advancesradonc.com advancesradonc.com/article/S2452-1094(23)00108-2/fulltext

Safety of Concurrent Radiation Therapy With Brentuximab ... In surviving patients, the median follow-up from BVRT to last follow-up was 6.2 months (IQR, 2.6-14.4 months). Twenty-four of 42 patients (57%) ...

9. thegreenjournal.com thegreenjournal.com/article/S0167-8140(25)00226-9/fulltext

Proton beam therapy for mediastinal Hodgkin lymphoma With a median follow-up of 32 (range 21–48) months, the local and distant progression-free survival rates were 95.5 % and 95.0 %, respectively.