To prospectively evaluate the efficacy and safety of large fraction radiation therapy combined with granulocyte-macrophage colony-stimulating factor, lenalidomide, and glofitamab monoclonal antibody in the treatment of refractory relapsed diffuse large B-cell lymphoma patients
Written informed consent must be obtained before any trial-related procedures are implemented.
Participants must be aged 18 or older, of any gender, with an expected survival period of more than 3 months.
ECOG PS score must be between 0-3.
Participants must have histopathologically confirmed diffuse large B-cell lymphoma.
B-cell non-Hodgkin's lymphoma with loss of CD20 expression.
Acute or chronic active Hepatitis B or C infection, Hepatitis B virus (HBV) DNA>2000IU/ml or 104 copies/ml; Hepatitis C virus (HCV) RNA>103 copies/ml; simultaneous positivity for Hepatitis B surface antigen (HbsAg) and anti-HCV antibody.
Participants have received anti-hematologic malignancy treatment within 2 weeks before the start of treatment or within 5 half-lives of the drug, whichever is longer.
Bone marrow insufficiency defined by platelet count <30 x 109/L or absolute neutrophil count <1.0 x 109/L.
Single group
Large fraction radiotherapy in combined with GM-CSF, Lenalidomide, and Glofitamab
DrugLarge fraction radiotherapy is administered at 5Gy/day for 3 days, with one to two courses carried out on a single target lesion as determined by the investigator. Granulocyte-macrophage colony-stimulating factor (GM-CSF) is administered at 400µg per day for 3 days starting on the first day after the end of radiotherapy. Lenalidomide is administered at 25mg per day for 14 days starting on the first day after the end of radiotherapy. Glofitamab is administered starting on the 7th day after the end of radiotherapy. For cycles 2-6, each cycle is 21 days. GM-CSF is administered at 400µg per day for 3 days starting on the first day of each cycle. Glofitamab is administered at 30mg on the 4th day of each cycle. Lenalidomide is administered at 25mg per day for 14 days starting on the first day. Treatment consists of 6 cycles or until disease progression, death, intolerable toxicity, withdrawal of informed consent.
CR
Complete remission rate, according to Lugano 2014 criteria.
ORR
Overall remission rate, according to Lugano 2014 criteria.
PFS
Progression-free survival
OS
Overall survival
Click on the lead sponsor to view all of their trials.
