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

NCT ID: NCT05823701

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2025-12-31

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.

Conditions

Diffuse Large B-Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chidamide, Azacitidine Combined With GM(CAGM) Regimen

R/R DLBCL patients were treated with 2 cycles of CAGM regimen including chidamide, azacitidine, obinutuzumab and liposomal mitoxantrone followed by imaging examination. Patients achieved CR/PR were exposed to ASCT/CAR-T therapy or additional 4 cycles of CAGM regimen in patients ineligible for ASCT/CAR-T therapy; whereas, patients with SD/PD were withdrawn from this study.

Group Type: EXPERIMENTAL

Chidamide

Intervention Type: DRUG

20 mg (4 capsules), d1, d4, d8, d11 orally per cycle

Azacitidine

Intervention Type: DRUG

100mg d1- d5 subcutaneous injection per cycle

obinutuzumab

Intervention Type: BIOLOGICAL

1000mg d4 intravenous infusion per cycle

Liposomal mitoxantrone

Intervention Type: DRUG

20mg/m2 d5 intravenous infusion per cycle

Interventions

Chidamide

20 mg (4 capsules), d1, d4, d8, d11 orally per cycle

Intervention Type: DRUG

Azacitidine

100mg d1- d5 subcutaneous injection per cycle

Intervention Type: DRUG

obinutuzumab

1000mg d4 intravenous infusion per cycle

Intervention Type: BIOLOGICAL

Liposomal mitoxantrone

20mg/m2 d5 intravenous infusion per cycle

Intervention Type: DRUG

Other Intervention Names

Tucidinostat; AZA; Gazyva; PLM60

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhengming Jin

Role: CONTACT

jinzhengming519519@163.com

67781856

Changju Qu

Role: CONTACT

qcj310@163.com

67781856

Facility Contacts

Zhengming Jin

Role: primary

Other Identifiers

Jinzm003

Identifier Type: -

Identifier Source: org_study_id