NCT03681535Active, not recruiting
Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma
Phase II Study of Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 243 (actual)
- First submitted
- 20 Sept 2018
- Start date
- 13 Feb 2019
- Primary completion date
- 10 Jul 2025
- Lead sponsor
- Duke University
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT03681535
What you commit to
- Study type: Interventional
- Participants enrolled: 243
- From 13 Feb 2019 to the primary completion date, 10 Jul 2025
- 12 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any absolute contraindications to irradiation
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Motol Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| University of Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Juntendo University Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| National Cancer Center of Singapore Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Rochester James P Wilmot Cancer Institute Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital Coordinator of this site? Confirm its status | Weymouth | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.