Phase II study of Dose-Reduced Consolidation Radiation Therapy in Patients with Diffuse Large B-cell Lymphoma
Trial Description
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 Requirements
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