Clinical trial NCT05823701: Chidamide, Azacitidine Combined With GM Regimen for Relapsed and Refractory DLBCL Patients
Official title: A Phase 2 Study of Chidamide, Azacitidine Combined With GM Regimen for Patients With Relapsed and Refractory DLBCL
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diffuse Large B-Cell Lymphoma
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall response rate(ORR)
timeFrame: At the end of Cycle 2 (each cycle is 28 days)
measure: Complete response rate(CRR)
timeFrame: At the end of Cycle 2 (each cycle is 28 days)
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events
timeFrame: initiation of study drug until 30 days after last dose
measure: Progression-free survival(PFS)
timeFrame: Up to 24 months after the end of last patients' treatment.
measure: Overal survival(OS)
timeFrame: Up to 24 months after the end of last patients' treatment.
measure: Overall response rate(ORR)
timeFrame: At the end of Cycle 6 (each cycle is 28 days)
measure: Complete response rate(CRR)
timeFrame: At the end of Cycle 6 (each cycle is 28 days)
Other outcomes:
Locations:
city: Suzhou
country: China
facility: the First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References: