Diffuse large B-cell lymphoma
Conditions
Interventions
Experimental arm:PD-1 inhibitor plus Rosuvastatin arm
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Male or female, aged 18-65 years; 2.Diagnosed with DLBCL according to WHO 2016 guidelines, and having met the criteria for and successfully completed autologous stem cell transplantation (ASCT) after achieving CR or PR from prior treatment; 3.Laboratory tests meeting the following requirements prior to enrollment: White blood cell count >= 3.0 x 10^9/L Absolute neutrophil count >= 1.5 x 10^9/L Hemoglobin >= 90 g/L Platelet count >= 50 x 10^9/L Liver function: Transaminases = 30 mL/min Cardiac enzymes < 2 x ULN (for the corresponding age group) ECOG performance status score of 0-2; 4.All subjects must have provided written informed consent for this trial prior to participation, voluntarily signed by themselves (or their legally authorized representative). The subject or their legally authorized representative must be able to communicate effectively with the investigator and agree to comply with the protocol requirements to complete the trial.
Exclusion criteria
Exclusion criteria: 1.Women who are pregnant or breastfeeding, and individuals of childbearing potential who refuse to use contraception; 2.Inability to swallow, chronic diarrhea, intestinal obstruction, or the presence of multiple factors affecting drug administration and absorption; 3.Treatment history prior to the trial: Use of medications significantly affecting the P450 metabolic enzyme pathway within 2 weeks prior to screening. Current use of cyclosporine or fibrate drugs. Participation in another clinical study involving investigational drugs within 28 days before starting the study drug in this trial. Requirement for concomitant medications known to prolong QTc or induce Torsades de Pointes (TdP), except for antimicrobial agents used as standard prophylaxis/treatment for infection and other such drugs deemed critical by the investigator. 4.Evidence of currently uncontrolled cardiovascular disease, including uncontrolled hypertension, uncontrolled arrhythmia, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months. History of autoimmune disease requiring systemic treatment, or a syndrome requiring systemic corticosteroid/immunosuppressant use (e.g., hypophysitis, pneumonitis, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc.). Severe acute or chronic infection requiring systemic treatment. Known HIV infection, or active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection. History of uncontrolled epilepsy; presence of central nervous system disorders or psychiatric illnesses. Presence of severe unhealed wounds, ulcers, or fractures. History of Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN). History of myopathy such as myalgia, myositis, or rhabdomyolysis; 5.Known allergy or hypersensitivity to any study drug, its analogs, or any component of the drug formulations; 6.History of malignancies other than DLBCL, unless the patient has been in remission for over 3 years; 7.Lymphoma involving the central nervous system; 8.Any prior or current disease, treatment, or laboratory abnormality that might, in the investigator's judgment, interfere with the study results, affect the subject's full participation, or make the subject unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Immune cell function; | — |
Countries
China
Contacts
Public ContactJun Shi
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed