Radiation Therapy for Lymphoma

Overseen By Peter Riedell, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This study focuses on using shortened courses of radiation for participants with relapsed/refractory Hodgkin/Non-Hodgkin lymphoma. Treatment radiation over 5-6 weeks is often standard of care for many people with lymphoma, but doctors leading this study aim to find out if using radiation for a shorter period of time can be safe for treating lymphoma and if so, what is the safest shortened dose of radiation for participants.

Research Team

Yasmin Hasan, MD

Principal Investigator

University of Chicago - Comprehensive Cancer Center

Eligibility Criteria

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.

I need daily oxygen therapy due to heart disease.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+