Diffuse Large B-Cell Lymphoma
Conditions
Brief summary
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.
Detailed 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.
Interventions
DRUGChidamide
20 mg (4 capsules), d1, d4, d8, d11 orally per cycle
DRUGAzacitidine
100mg d1- d5 subcutaneous injection per cycle
BIOLOGICALobinutuzumab
1000mg d4 intravenous infusion per cycle
20mg/m2 d5 intravenous infusion per cycle
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years. 2. At least one measurable lesion，measurable lymph nodes or masses of at least 15 millimeter (mm). 3. Histopathologically confirmed DLBCL. 4. Diseases refractory to first-line treatment (including CD20 monoclonal antibody and anthracycline) or relapsed after the last treatment. 5. Life expectancy \> 3 months. 6. 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; 7. 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. 8. The patient has the ability to understand and is willing to provide written informed consent. 9. Agreement to practice birth control from the time of enrollment until the follow-up period of the study.
Exclusion criteria
1. Severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine \> 3 times the upper limit of normal); 2. Structural heart disease, leading to clinical symptoms or abnormal cardiac function (NYHA ≥ grade 2); 3. Uncontrolled active infection; 4. Concurrent presence of other tumors requiring treatment or intervention; 5. Current or expected need for systemic corticosteroid therapy; 6. Pregnant or lactating women. 7. Other psychological conditions that prevent patients from participating in the research or signing the informed consent. 8. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate(ORR) | At the end of Cycle 2 (each cycle is 28 days) | The rate of patients who achieved CR or PR after treatment by CAGM regimen |
| Complete response rate(CRR) | At the end of Cycle 2 (each cycle is 28 days) | The rate of patients who achieved CR after treatment by CAGM regimen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overal survival(OS) | Up to 24 months after the end of last patients' treatment. | OS will be assessed from the first CAGM given to date of death or end of follow-up. |
| Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events | initiation of study drug until 30 days after last dose | The safety and tolerability of the therapeutic regimen measured by the incidence of treatment-emergent adverse events, treatment-related adverse events and serious adverse events. |
| Complete response rate(CRR) | At the end of Cycle 6 (each cycle is 28 days) | The rate of patients who achieved CR after treatment by CAGM regimen |
| Overall response rate(ORR) | At the end of Cycle 6 (each cycle is 28 days) | The rate of patients who achieved CR or PR after treatment by CAGM regimen |
| Progression-free survival(PFS) | Up to 24 months after the end of last patients' treatment. | PFS will be assessed from the first CAGM given to date of progression, relapse, death or end of follow-up. |
Countries
China
Contacts
Primary ContactZhengming Jin
Backup ContactChangju Qu
Outcome results
None listed