Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma

Running, not enrolling · Not applicable

Conditions studied: Diffuse Large B Cell Lymphoma

In brief

This phase II study will evaluate whether a reduction in radiation dose and field size will maintain a high rate of local control while minimizing the risk of acute and late toxicity . Hypothesis: The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy while maintaining high rates of local control in patients who had a negative PET-CT scan following rituximab - containing chemotherapy.

Key facts

Study ID

NCT03681535

Run by

Duke University

People needed

243

Starts

2019-02-13

Expected to finish

2028-07-01

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Completion of at least 3 cycles of rituximab-containing, anthracycline-based combination chemotherapy
• 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
• Absolute neutrophil count greater than 1000 and platelet count greater than 40,000
• Negative pregnancy test in women of child-bearing potential
• Signed study specific informed consent

You may not qualify if…

• Primary central nervous system lymphoma, primary cutaneous DLBCL, leg type. T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal (thymic) large B-cell lymphoma, or other distinct non-Hodgkin lymphomas arising from large B-cells included in the WHO classification
• Any absolute contraindications to irradiation

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital — Weymouth, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Rochester James P. Wilmot Cancer Institute — Rochester, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• University Hospital Motol — Prague, Czechia
• University of Torino — Torino, Italy
• Juntendo University — Tokyo, Japan
• National Cancer Center of Singapore — Singapore, Singapore
• Yonsei University Health System — Seoul, South Korea

Full record on ClinicalTrials.gov

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