Chidamide, Azacitidine Combined With GM Regimen for Relapsed and Refractory DLBCL Patients

Diffuse Large B-Cell Lymphoma Clinical Trial

Official title:

A Phase 2 Study of Chidamide, Azacitidine Combined With GM Regimen for Patients With Relapsed and Refractory DLBCL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05823701
• Other study ID #: Jinzm003
• Status: Recruiting
• Phase: Phase 2
• Start date: September 30, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2022
• Source: The First Affiliated Hospital of Soochow University
• Contact: Zhengming Jin
• Phone: 67781856
• Email: jinzhengming519519[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Chidamide
20 mg (4 capsules), d1, d4, d8, d11 orally per cycle
• Azacitidine
100mg d1- d5 subcutaneous injection per cycle

Biological:
• obinutuzumab
1000mg d4 intravenous infusion per cycle

Drug:
• Liposomal mitoxantrone
20mg/m2 d5 intravenous infusion per cycle

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate(ORR)	The rate of patients who achieved CR or PR after treatment by CAGM regimen	At the end of Cycle 2 (each cycle is 28 days)
Primary	Complete response rate(CRR)	The rate of patients who achieved CR after treatment by CAGM regimen	At the end of Cycle 2 (each cycle is 28 days)
Secondary	Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events	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.	initiation of study drug until 30 days after last dose
Secondary	Progression-free survival(PFS)	PFS will be assessed from the first CAGM given to date of progression, relapse, death or end of follow-up.	Up to 24 months after the end of last patients' treatment.
Secondary	Overal survival(OS)	OS will be assessed from the first CAGM given to date of death or end of follow-up.	Up to 24 months after the end of last patients' treatment.
Secondary	Overall response rate(ORR)	The rate of patients who achieved CR or PR after treatment by CAGM regimen	At the end of Cycle 6 (each cycle is 28 days)
Secondary	Complete response rate(CRR)	The rate of patients who achieved CR after treatment by CAGM regimen	At the end of Cycle 6 (each cycle is 28 days)