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

NOT ENROLLING
Protocol # :
19-298
Conditions
Diffuse Large B Cell Lymphoma
Phase
II
Disease Sites
Non-Hodgkin's Lymphoma
Principal Investigator
Ng, Andrea, K.
Site Investigator
Pashtan, Itai
Patel, Chirayu, G.
Powlis, William, D.
Site Research Nurses
Mann, Eileen, Marie
Roper, Kristin
Spicer, Beverly, A.

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

19-298