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

NCT05823701 | Unknown Phase 2

• 1 other identifier: Jinzm003
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

• Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events

  initiation of study drug until 30 days after last dose

• Progression-free survival(PFS)

  Up to 24 months after the end of last patients' treatment.

• Overal survival(OS)

  Up to 24 months after the end of last patients' treatment.

• Overall response rate(ORR)

  At the end of Cycle 6 (each cycle is 28 days)

• Complete response rate(CRR)

  At the end of Cycle 6 (each cycle is 28 days)

Study Arms (1)

Chidamide, Azacitidine Combined With GM(CAGM) Regimen

EXPERIMENTAL

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or additional 4 cycles of CAGM regimen in patients ineligible for ASCT/CAR-T therapy; whereas, patients with SD/PD were withdrawn from this study.

Drug: Chidamide; Drug: Azacitidine; Biological: obinutuzumab; Drug: Liposomal mitoxantrone

Interventions

Chidamide DRUG

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

Also known as: Tucidinostat

Chidamide, Azacitidine Combined With GM(CAGM) Regimen

Azacitidine DRUG

100mg d1- d5 subcutaneous injection per cycle

Also known as: AZA

Chidamide, Azacitidine Combined With GM(CAGM) Regimen

obinutuzumab BIOLOGICAL

1000mg d4 intravenous infusion per cycle

Also known as: Gazyva

Chidamide, Azacitidine Combined With GM(CAGM) Regimen

Liposomal mitoxantrone DRUG

20mg/m2 d5 intravenous infusion per cycle

Also known as: PLM60

Chidamide, Azacitidine Combined With GM(CAGM) Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Azacitidine; obinutuzumab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

Zhengming Jin

CONTACT

67781856; jinzhengming519519@163.com

Changju Qu

CONTACT

67781856; qcj310@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: April 21, 2023
• Study Start: September 30, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: April 21, 2023

Record last verified: 2022-08

Locations

CN (1)