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Trial Title:
Chidamide, Azacitidine Combined With GM Regimen for Relapsed and Refractory DLBCL Patients
NCT ID:
NCT05823701
Condition:
Diffuse Large B-Cell Lymphoma
Conditions: Official terms:
Lymphoma, Large B-Cell, Diffuse
Azacitidine
Mitoxantrone
Obinutuzumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chidamide
Description:
20 mg (4 capsules), d1, d4, d8, d11 orally per cycle
Arm group label:
Chidamide, Azacitidine Combined With GM(CAGM) Regimen
Other name:
Tucidinostat
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
100mg d1- d5 subcutaneous injection per cycle
Arm group label:
Chidamide, Azacitidine Combined With GM(CAGM) Regimen
Other name:
AZA
Intervention type:
Biological
Intervention name:
obinutuzumab
Description:
1000mg d4 intravenous infusion per cycle
Arm group label:
Chidamide, Azacitidine Combined With GM(CAGM) Regimen
Other name:
Gazyva
Intervention type:
Drug
Intervention name:
Liposomal mitoxantrone
Description:
20mg/m2 d5 intravenous infusion per cycle
Arm group label:
Chidamide, Azacitidine Combined With GM(CAGM) Regimen
Other name:
PLM60
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
the First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengming Jin
Start date:
September 30, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05823701
