Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT03681535

Active Not RecruitingNA

Sponsor: Duke University

Conditions: Diffuse Large B Cell Lymphoma

Interventions: Radiation Therapy

Countries: United States, Czechia, Italy, Japan, Singapore, South Korea

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (12)
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Weymouth, Massachusetts, United States
  • St Louis, Missouri, United States
  • Rochester, New York, United States
  • Durham, North Carolina, United States
  • Houston, Texas, United States
  • Prague, Czechia
  • Torino, Italy
  • Tokyo, Japan
  • Singapore, Singapore
  • Seoul, South Korea