Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Efficacy and Safety of Glofitamab Combined with GemOx (Gemcitabine and Oxaliplatin) in the Treatment of Refractory Diffuse Large B-Cell Lymphoma.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
