Efficacy and Safety of Glofitamab Combined With GemOxin the Treatment of Refractory Diffuse Large B-Cell Lymphoma

Efficacy and Safety of Glofitamab Combined With GemOx (Gemcitabine and Oxaliplatin) in the Treatment of Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Multicenter, Single-Arm, Phase II Study

In patients with relapsed or refractory diffuse DLBCL who have not achieved complete remission in the mid-term, the treatment with Glofit+GemOx regimen is used.

Efficacy and Safety of Glofitamab Combined with GemOx (Gemcitabine and Oxaliplatin) in the Treatment of Refractory Diffuse Large B-Cell Lymphoma.

Inclusion Criteria:

• Age ≥ 18 years;
• DLBCL confirmed by pathological diagnosis according to the WHO 2016 classification;
• PET-positive (Deauville score 4-5) according to Lugano response criteria after 3 cycles of first-line treatment;
• No history or evidence of central nervous system involvement;
• Adverse reactions from prior treatments have recovered to grade 1 or below (excluding clinically insignificant reactions such as hair loss);
• ECOG performance status score ≤ 2;
• Adequate bone marrow, kidney, liver, respiratory, and cardiac function: absolute neutrophil count ≥ 1000/μL; platelet count ≥ 75,000/μL; absolute lymphocyte count ≥ 100/μL; creatinine clearance ≥ 60 mL/min; ALT and AST ≤ 2.5 times the upper limit of normal; total bilirubin ≤ 1.5 mg/dL (except for Gilbert's syndrome); cardiac echocardiography showing ejection fraction ≥ 50% with no pericardial effusion (small or physiological effusions excluded); no clinically significant serosal effusions; baseline oxygen saturation > 92%;
• The subject is able to understand the study protocol, is willing to participate in this study, and provides written informed consent.

Exclusion Criteria:

• History of malignant tumors, excluding non-melanoma skin cancers or carcinoma in situ (cervix, bladder, breast), unless the disease has been in remission for at least 3 years;
• Uncontrolled fungal, bacterial, viral, or other infections requiring intravenous anti-infective therapy;
• Human immunodeficiency virus (HIV) infection, or acute/chronic active hepatitis B or C infection;
• Malignant cells detectable in cerebrospinal fluid or active CNS lymphoma;
• History of myocardial infarction, coronary artery bypass graft, or stent implantation within 12 months prior to enrollment;
• History of deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment;
• Female patients who are pregnant or breastfeeding, as determined by the investigator;
• Inability of the subject to complete the study protocol or visits;
• Presence of uncontrollable infection;
• Currently participating in interventional study treatment, or having received other investigational drugs within 4 weeks prior to first dose (previous treatment with cetuximab, oxaliplatin, and gemcitabine is included);
• Any other condition that the investigator deems the patient unsuitable for this trial.