Overview
To evaluate the efficacy and safety of CAGM regimen in R/R DLBCL patients and to provide a safe and more effective approach for R/R DLBCL patients.
Description
The study will start with an initial 2 cycles of induction therapy with CAGM containing chidamide, azacitidine, obinutuzumab and mitoxantrone liposome, orelabrutinib and rituximab，following imaging examinations to evaluate response rates. For patients feasible to CAR-T/ASCT, sequential CAR-T/ASCT treatment was given. For patients who were unable to undergo CAR-T/ASCT, 4 cycles of CAGM immunochemotherapy were carried out. Efficacy and safety of CAGM regimen in R/R DLBCL will be evaluated.
Eligibility
Inclusion Criteria:
- Age ≥ 18 years.
- At least one measurable lesion，measurable lymph nodes or masses of at least 15 millimeter (mm).
- Histopathologically confirmed DLBCL.
- Diseases refractory to first-line treatment (including CD20 monoclonal antibody and anthracycline) or relapsed after the last treatment.
- Life expectancy > 3 months.
- Appropriate organ function: Cardiac function: cardiac ejection fraction ≥50%; Liver function: alanine aminotransferase and aspartate aminotransferase ≤3 times the upper limit of normal; Renal function: serum creatinine clearance ≥30 mL/min; Lung function: SPO2>91% without oxygen;
- Adequate bone marrow reserve: Hemoglobin ≥8 g/dL; Platelet count ≥75×10^9/L; Absolute neutrophil value ≥1.0×10^9/L; Platelet count ≥50×10^9/L, absolute neutrophil value ≥0.75×10^9/L if there is bone marrow invasion.
- The patient has the ability to understand and is willing to provide written informed consent.
- Agreement to practice birth control from the time of enrollment until the follow-up period of the study.
Exclusion Criteria:
- Severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine > 3 times the upper limit of normal);
- Structural heart disease, leading to clinical symptoms or abnormal cardiac function (NYHA ≥ grade 2);
- Uncontrolled active infection;
- Concurrent presence of other tumors requiring treatment or intervention;
- Current or expected need for systemic corticosteroid therapy;
- Pregnant or lactating women.
- Other psychological conditions that prevent patients from participating in the research or signing the informed consent.
- In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or does not meet the requirements for participation in the study.