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Radiation Therapy

Reduced-Dose Radiation Therapy for Diffuse Large B-cell Lymphoma (DLBCL Trial)

N/A
Waitlist Available
Led By Christopher Kelsey, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic documentation of stage I-IV diffuse large B-cell lymphoma, not otherwise specified (DLBCL NOS), as defined by the 2016 WHO classification. This would include all entities within this category including germinal center B-cell and non-germinal center B-cell subtypes and those with a double expressor phenotype. Also eligible are stage I-IV high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements and high-grade B-cell lymphoma, NOS
Negative post-chemotherapy PET-CT scan or negative interim PET-CT scan performed within 2 weeks of the final cycle of chemoimmunotherapy. This is defined as a score of 1-3 on the PET Five Point (Deauville) Scale using the Modified Lugano Response Criteria for Non-Hodgkin's Lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

DLBCL Trial Summary

This trial will help researchers learn if a lower dose of radiation is just as effective as a higher dose in treating cancer while minimizing side effects.

Who is the study for?
This trial is for adults with a type of cancer called diffuse large B-cell lymphoma. Participants must have completed certain chemotherapy, show no signs of cancer on recent PET-CT scans, and have adequate blood cell counts. Pregnant women and those with specific other lymphoma types or conditions that make radiation unsafe cannot join.Check my eligibility
What is being tested?
The study is testing if lower doses of radiation therapy (20 Gy instead of the usual 30 Gy) can still effectively control this lymphoma without causing as many side effects. It's for patients who responded well to initial chemo treatments.See study design
What are the potential side effects?
Radiation therapy may cause skin irritation at the treatment site, fatigue, nausea, and could potentially lead to long-term risks like secondary cancers or heart issues in some patients.

DLBCL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lymphoma is a specific type called DLBCL or high-grade B-cell lymphoma.
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My recent PET-CT scan shows no signs of cancer after treatment.
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I have completed at least 3 cycles of a specific chemotherapy that includes rituximab and anthracycline.

DLBCL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Local control rate
Secondary outcome measures
Disease-free survival
Overall Survival
Patterns of failure

DLBCL Trial Design

1Treatment groups
Experimental Treatment
Group I: Single arm interventional studyExperimental Treatment1 Intervention
RT to 19.5-20Gy is given after 3 cycles of rituximab containing chemotherapy. RT is administered daily, 5 days per week in 1.5-2Gy fractions (treatments).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,265 Total Patients Enrolled
Christopher Kelsey, MDPrincipal InvestigatorDuke Health
3 Previous Clinical Trials
97 Total Patients Enrolled

Media Library

Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03681535 — N/A
Non-Hodgkin's Lymphoma Research Study Groups: Single arm interventional study
Non-Hodgkin's Lymphoma Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT03681535 — N/A
Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03681535 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which types of individuals meet the criteria for participating in this clinical investigation?

"To qualify for this trial, patients must have lymphoma and be between 18-80 years of age. In total, the program is hoping to recruit 240 participants."

Answered by AI

How many participants are recruited for this experiment?

"Yes, according to the information on clinicaltrials.gov this trial is currently accepting volunteers. The study was first published on February 13th 2019 and most recently updated in July 19th 2022. This research requires 240 participants located over 9 sites."

Answered by AI

Is the enrollment of participants aged 35 and above open for this experiment?

"To be eligible for this medical trial, applicants must fall between 18 and 80 years of age. There are 307 clinical trials designed to help minors while there are 1622 such studies intended for individuals over the age of 65."

Answered by AI

In how many locations can participants access this research endeavor?

"There are currently 9 clinical sites that are enrolling patients for this trial. These include Duke University Medical Center in Durham, Dana-Farber/Brigham and Women's Cancer Center with South Shore Hospital in Weymouth, and MD Anderson Cancer Centre of Houston; the other 6 locations can be found online."

Answered by AI

Is the enrollment period for this study still open?

"Correct. The clinical trial has been advertised on clinicaltrials.gov since February 13th 2019 and was last updated on July 19th 2022, with the aim of enrolling 240 participants across 9 different medical centres."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma
2019. "Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03681535.
~47 spots leftby Aug 2025
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