- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05823701
Chidamide, Azacitidine Combined With GM Regimen for Relapsed and Refractory DLBCL Patients
April 10, 2023 updated by: The First Affiliated Hospital of Soochow University
A Phase 2 Study of Chidamide, Azacitidine Combined With GM Regimen for Patients With Relapsed and Refractory DLBCL
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
23
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhengming Jin
- Phone Number: 67781856
- Email: jinzhengming519519@163.com
Study Contact Backup
- Name: Changju Qu
- Phone Number: 67781856
- Email: qcj310@163.com
Study Locations
-
-
Jiangsu
-
Suzhou, Jiangsu, China, 215006
- Recruiting
- The First Affiliated Hospital of Soochow University
-
Contact:
- Zhengming Jin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
20 mg (4 capsules), d1, d4, d8, d11 orally per cycle
Other Names:
100mg d1- d5 subcutaneous injection per cycle
Other Names:
1000mg d4 intravenous infusion per cycle
Other Names:
20mg/m2 d5 intravenous infusion per cycle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate(ORR)
Time Frame: 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
|
At the end of Cycle 2 (each cycle is 28 days)
|
Complete response rate(CRR)
Time Frame: At the end of Cycle 2 (each cycle is 28 days)
|
The rate of patients who achieved CR after treatment by CAGM regimen
|
At the end of Cycle 2 (each cycle is 28 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events
Time Frame: 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.
|
initiation of study drug until 30 days after last dose
|
Progression-free survival(PFS)
Time Frame: 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.
|
Up to 24 months after the end of last patients' treatment.
|
Overal survival(OS)
Time Frame: 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.
|
Up to 24 months after the end of last patients' treatment.
|
Overall response rate(ORR)
Time Frame: 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
|
At the end of Cycle 6 (each cycle is 28 days)
|
Complete response rate(CRR)
Time Frame: At the end of Cycle 6 (each cycle is 28 days)
|
The rate of patients who achieved CR after treatment by CAGM regimen
|
At the end of Cycle 6 (each cycle is 28 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2022
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2025
Study Registration Dates
First Submitted
February 27, 2023
First Submitted That Met QC Criteria
April 10, 2023
First Posted (Actual)
April 21, 2023
Study Record Updates
Last Update Posted (Actual)
April 21, 2023
Last Update Submitted That Met QC Criteria
April 10, 2023
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Azacitidine
- Mitoxantrone
- Obinutuzumab
Other Study ID Numbers
- Jinzm003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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