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

NCT03681535 | Active Not Recruiting

• 1 other identifier: Pro00100510
• Study Type: interventional
• Target: 241
• Locations: 6 countries
• Sites: 12

Brief 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.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

DLBCL; Reduce radiation dose

Outcome Measures

Primary Outcomes (1)

• Local control rate

  Local control rate of 95% measured by standard of care imaging obtained per the National Comprehensive Cancer Network guidelines

  2 years

Secondary Outcomes (3)

• Disease-free survival

  5 years

• Overall Survival

  5 years

• Patterns of failure

  5 years

Study Arms (1)

Single arm interventional study

EXPERIMENTAL

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).

Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

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.

Single arm interventional study

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (12)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital

Weymouth, Massachusetts, 02190, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Rochester James P. Wilmot Cancer Institute

Rochester, New York, 14642, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University Hospital Motol

Prague, Czechia

Location

University of Torino

Torino, Italy

Location

Juntendo University

Tokyo, Japan

Location

National Cancer Center of Singapore

Singapore, Singapore

Location

Yonsei University Health System

Seoul, South Korea

Location

Related Publications (1)

• Kelsey CR, Broadwater G, James O, Chino J, Diehl L, Beaven AW, Chang C, Koontz BF, Prosnitz LR. Phase 2 Study of Dose-Reduced Consolidation Radiation Therapy in Diffuse Large B-Cell Lymphoma. Int J Radiat Oncol Biol Phys. 2019 Sep 1;105(1):96-101. doi: 10.1016/j.ijrobp.2019.02.055. Epub 2019 Mar 8.

  PMID: 30858144 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Christopher Kelsey, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 24, 2018
• Study Start: February 13, 2019
• Primary Completion: July 10, 2025
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1); IT (1); CZ (1); SG (1); KR (1); US (7)