Diffuse large B-cell lymphoma
Conditions
Interventions
Test group:Adebrelimab+Rituximab+CHOP
Sponsors
Jiangnan University Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1, Aged between 18-75 years, male/female participants have a histologically confirmed PD-L1-positive (CPS score >1) DLBCL diagnosis on the day of signing the informed consent form. 2, Male participants must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment. During this period, participants must refrain from sperm donation. 3, A female participant is eligible to participate if she is not pregnant, not breastfeeding, and meets one of the following conditions: a) Is not a woman of childbearing potential (WOCBP). b) WOCBP agrees to comply with contraceptive instructions during treatment and for at least 120 days after the last dose of study treatment. c) If a woman of childbearing potential, a negative pregnancy test must be performed within 72 hours prior to the start of treatment. 4, Participant (if applicable) provides informed consent for the trial in writing. 5. Presence of measurable disease, defined as at least one lesion that can be accurately measured by CT scanning in at least two dimensions. The minimum measurements required are: long diameter >15mm and short diameter >10mm. 6Participants must provide archived biopsy material (preferably performed prior to enrollment) for use in relevant studies. 7Eastern Cooperative Oncology Group Physical Status Score (ECOG PS) 0-1. 8. Test results suggesting adequate organ function within 10 days prior to treatment. Please see below for laboratory test values: a) Blood count: Absolute neutrophil count (ANC) = 1.0 x 109/L; Platelet count (PLT) = 75 x 109/L, or = 50 x 109/L if lymphoma involves bone marrow (no platelet transfusion within 7 days prior to the test); Hemoglobin (HGB) = 8 g/dL (no transfusion within 14 days prior to the test); b) Coagulation function: International Normalized Ratio (INR) =1.5, partial thromboplastin time (aPTT) =1.5 times the upper limit of normal value; c) Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) = 2.5 times the upper limit of normal; serum total bilirubin = 1.5 times the upper limit of normal (Gilbert's syndrome = 3 times the upper limit of normal); d) Renal function: serum creatinine clearance (CrCl) =30 mL/min according to the Cockcroft-Gault formula; 9. Expected survival > 4 months.
Exclusion criteria
Exclusion criteria: Patients with any of the following are not eligible for enrollment in this study: 1. a positive urine pregnancy test within 72 hours prior to starting study treatment. If the urine test is positive or unconfirmed negative, a serum pregnancy test will be required. 2. prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or prior treatment with drugs targeting other stimulatory or co-suppressive T-cell receptors (e.g. CTLA-4, OX-40, CD137). 3. prior anti-lymphoma therapy, including corticosteroids, radiation therapy, chemotherapy, targeted therapy, or immunotherapy. Note: Prior treatment with corticosteroids (duration <10 days) to alleviate lymphoma-related symptoms or to prevent tumor lysis syndrome is permitted. Note: If the subject has undergone major surgery, he/she must have recovered sufficiently prior to initiating study treatment. 4. received a live vaccine within 30 days prior to receiving the first dose of study drug. Examples of live vaccines include, but are not limited to: measles, mumps, rubella, varicella/herpes zoster (chickenpox), yellow fever, rabies, bacillus Calmette-Guérin (BCG), and typhoid vaccines. Injectable seasonal influenza vaccines that normally kill the virus are permitted; however, nasal influenza vaccines (e.g., FluMist®) are active attenuated vaccines and are not permitted. 5. current participation or participation in a study investigating an investigational agent or investigational device within 4 weeks prior to the first dose of investigational therapy. 6. in addition to the short-term corticosteroid use described above for control of symptoms associated with lymphoma, a diagnosis of immunodeficiency or chronic systemic steroid therapy (at doses greater than the equivalent of a 10 mg daily prednisone equivalent dose) within 7 days prior to the first dose of investigational drug. 7. other malignancy known to be ongoing or requiring active treatment within the past 2 years. Note: Patients with basal cell skin cancer, squamous cell skin cancer, or carcinoma in situ (e.g., breast cancer, cervical cancer in situ) who have received treatment that may have curative potential are not excluded. Other exceptions may be allowed after discussion with the principal investigator. 8. known CNS invasion by lymphoma. 9. diagnosis of high-grade B-cell lymphoma (double/triple-hit lymphoma) with MYC and BCL2 and/or BCL6 gene rearrangements, primary mediastinal lymphoma, gray zone lymphoma, composite lymphoma, or previously untreated low-grade lymphoma with transformation to DLBCL disease. 10. severe hypersensitivity reaction (= grade 3) to PD-1 inhibitors and/or their excipients. 11. active autoimmune disease requiring systemic therapy (i.e., treatment with disease modifiers, corticosteroids, or immunosuppressive drugs) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary hypoplasia, etc.) is not considered a form of systemic therapy. 12. a history of (non-infectious) pneumonia requiring steroid therapy or the current presence of pneumonia. 13. the presence of an active infection requiring systemic therapy. 14. a known history of human immunodeficiency virus (HIV) infection 15. known hepatitis B (defined as hepatitis B surface antigen [HBsAg] positive, hepatitis B core [HBc] antibody positive, or detectable hepatitis B virus) or known active hepatitis C virus infection (defined as detectable HCV RNA). Note
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate at 18 weeks;Complete remission rate at 24 months;Progression-free survival at 24 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival at 18 weeks;Number of treatment-related adverse events assessed according to CTCAE v 5.0; | — |
Countries
China
Contacts
Public ContactTingxun Lu
Jiangnan University Affiliated Hospital
Outcome results
None listed