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Radiation Therapy

Reduced Dose Radiotherapy for Non-Hodgkin's Lymphoma

Phase 2
Recruiting
Led By Bradford S. Hoppe, MD, MPH
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3
Must not have
Men or women of childbearing potential who are unwilling to employ adequate contraception
T-cell lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 days after radiation treatment
Awards & highlights

Summary

"This trial is comparing a lower dose of radiation therapy to the standard dose in treating patients with a type of slow-growing lymphoma. Radiation therapy uses high energy to kill cancer cells. The standard treatment usually

Who is the study for?
This trial is for patients with a slow-growing type of blood cancer called indolent non-Hodgkin lymphoma. It's specifically for those who have seen their disease return after treatment. Participants should be able to undergo radiation therapy and other imaging procedures like CT scans or PET scans.
What is being tested?
The study is testing if giving a lower dose of radiation in just 3 treatments can be as effective and safer than the standard 12 treatments for this lymphoma. Patients will also undergo diagnostic tests, such as CT scans, endoscopic procedures, PET scans, and answer questionnaires.
What are the potential side effects?
Reduced dose radiation may lead to fewer side effects compared to standard doses but can still include skin irritation at the treatment site, fatigue, mild swelling or pain around treated areas. Long-term risks might involve changes in blood counts or rare secondary cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can take care of myself but may not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not willing to use birth control.
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My condition is T-cell lymphoma.
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My condition is Grade 3B follicular lymphoma.
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My condition is small or chronic lymphocytic lymphoma.
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I am currently breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 days after radiation treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 days after radiation treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of grade 2 or higher acute adverse events (AEs)
Secondary outcome measures
Patient reported quality of life
Response rate
Time to progression rate

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ARM 1 (reduced dose ISRT)Experimental Treatment5 Interventions
Patients undergo reduced dose ISRT once daily (excluding weekends) over 3 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up.
Group II: ARM 2 (SOC ISRT)Active Control5 Interventions
Patients undergo standard of care (SOC) radiation therapy once daily (excluding weekends) over 12 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endoscopic Procedure
2015
N/A
~250
Computed Tomography
2017
Completed Phase 2
~2740
Positron Emission Tomography
2011
Completed Phase 2
~2200

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,405 Total Patients Enrolled
Bradford S. Hoppe, MD, MPHPrincipal InvestigatorMayo Clinic
~27 spots leftby May 2026
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