Diffuse large B-cell lymphoma
Conditions
Interventions
Experimental group:glofitamab in combination with gemcitabine, dexamethasone, and cisplatin (Glofit-GDP)
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. According to the WHO 5th edition classification of lymphoid and hematopoietic tumors, the patient is pathologically diagnosed with DLBCL (including transformed DLBCL from indolent lymphoma, PMBCL, HGBCL); 2. Relapsed/refractory (R/R) disease is defined as follows: relapsed disease is disease that recurs =6 months after completing first-line treatment; refractory disease is disease that progresses during first-line treatment or within 6 months (=18 years; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 6. PET-CT or CT/MRI showing at least one bidimensionally measurable lesion: lymph node lesion >1.5 cm or other non-lymph node lesion >=1.0 cm; 7. Women of childbearing potential must have a negative pregnancy test and be willing to use effective contraception during the study and for at least 12 months after the last dose; pregnant and breastfeeding women cannot participate; all male participants must use contraception during the study and for at least 3 months after the last dose; 8. Adequate major organ function: (1) Hematologic function: absolute neutrophil count >= 1,000/mm^3, platelet count >= 75,000/mm^3; (2) Liver function: ALT/AST 30 mL/min, creatinine =95%; (5) Cardiac function: no significant heart failure or cardiovascular disease; 9. Expected survival >12 weeks; 10. Able to provide informed consent and understand and comply with all study requirements.
Exclusion criteria
Exclusion criteria: 1. Subjects are judged by the investigator to have any factors that may affect protocol compliance, including uncontrollable medical, psychological, familial, sociological, or geographical conditions, or an unwillingness or inability to comply with the procedures required by the study protocol; 2. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infections at the time of study enrollment (excluding nail fungal infections), or any major infection occurring within 4 weeks prior to the first study treatment (as assessed by the investigator); 3. Known human immunodeficiency virus (HIV) infection or positive immune testing; 4. Viral infections not controlled by antiviral drugs, such as active herpes virus infection, acute or chronic active hepatitis B, acute or chronic active hepatitis C, etc. (Note: Chronic HBV carriers or subjects who are HBsAg positive but inactive and with HBV-DNA below the detection limit may be enrolled with clinical evaluation, and preventive antiviral treatment should be administered if appropriate; HCV antibody-negative subjects may be enrolled, while HCV antibody-positive subjects require HCV-RNA testing, and may be enrolled if negative); 5. Patients with uncontrolled central nervous system infiltration of lymphoma (patients diagnosed with CNS disease at initial diagnosis are allowed, provided they achieve and maintain complete remission of CNS disease and have no CNS disease at relapse); 6. Patients who have previously been treated with cetuximab, gemcitabine, or cisplatin; 7. Patients who have previously undergone hematopoietic stem cell transplantation; 8. Patients allergic to the study drug or its excipients, or who have contraindications to the study drug; 9. Pregnant or breastfeeding patients; 10. Other severe diseases or medical conditions that may hinder participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate;Rate of transition to transplant;Event Free Survival ;Progression-free survival;Overall survival;safety; | — |
Countries
China
Contacts
Public ContactZhen Cai
The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed