The goal of this clinical trial is to learn if Glofitamab works for consolidation after first-line treatment of high-risk Large B-cell Lymphoma (LBCL). It will also learn about the safety of Glofitamab treatment. The main questions it aims to answer are:
* Does Glofitamab treatment result in prolonged clinical benefit to patients with high-risk LBCL after first-line treatment? * What medical problems do participants have when receiving Glofitamab treatment?
In this investigator-initiated, single-arm clinical trial, participants will:
* Receive Glofitamab treatment as per the instructions in the package insert. * Visit the clinic as instructed for checkups and tests.
Understand and voluntarily sign the informed consent form.
Age 18-75 years (inclusive, including 18 and 75 years) at screening; no restriction on gender.
Aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN); alanine aminotransferase (ALT) ≤3 times ULN; total serum bilirubin ≤2 times ULN, unless Gilbert syndrome is present. Patients with Gilbert syndrome can be included if total bilirubin ≤3 times ULN and direct bilirubin ≤1.5 times ULN.
Serum creatinine ≤1.5 times ULN or creatinine clearance ≥60 mL/min (using Cockcroft-Gault formula: Male CrCl = [(140-age) × weight (kg)] / [0.818 × creatinine (μmol/L)]; Female CrCl = [(140-age) × weight (kg) × 0.85] / [0.818 × creatinine (μmol/L)]).
History of severe allergy or hypersensitivity reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins).
Received autologous hematopoietic stem cell transplantation (ASCT) within 100 days prior to the first dose of Glofitamab; received chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to the first dose of Glofitamab.
Previously underwent allogeneic stem cell transplantation or allogeneic CAR-T therapy.
History of solid organ transplantation.
Single group
Glofitamab treatment
Biological/Vaccineeceive Glofitamab treatment as per the instructions in the package insert.
two year PFS
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This trial is not recruiting at the moment. You can still explore other options:
