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Active, not recruiting Not applicable

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

NCT03681535 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2019-02-13
Last updated
2026-07-07

Condition(s) studied

Diffuse Large B Cell Lymphoma

Investigational drug(s) / intervention(s)

Radiation Therapy

Radiation Therapy: This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve complete response and have a negative post-chemotherapy PET scan following 3 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Local Control Rate — 2 years
    Local control rate defined as the proportion of participants with absence of disease recurrence within the radiation therapy field as measured by standard of care imaging obtained per the National Comprehensive Cancer Network guidelines

Trial sites (12)

FacilityCityRegionStatus
Massachusetts General Hospital Boston Massachusetts
Dana Farber Cancer Institute Boston Massachusetts
Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital Weymouth Massachusetts
Washington University School of Medicine St Louis Missouri
University of Rochester James P. Wilmot Cancer Institute Rochester New York
Duke University Medical Center Durham North Carolina
MD Anderson Cancer Center Houston Texas
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03681535 on ClinicalTrials.gov ↗ ← All trials in Italy