Efficacy and safety of chidamide in combination with the R-mini CHOP regimen, followed by chidamide plus CD20 monoclonal antibody as maintenance therapy, in elderly patients with newly diagnosed MYC/BCL2 double-expressor DLBCL.
The primary study objective is to evaluate the 2-year progression-free survival (PFS) rate of chidamide in combination with the R-miniCHOP regimen. Secondary objectives include the objective response rate (ORR), duration of response (DOR), complete response (CR) rate, the percentage of patients converting from PR/SD to CR/PR, overall survival (OS), and safety parameters. The exploratory objective is to investigate the correlation between biomarkers (e.g., tumor genomics, proteomics) and ctDNA with treatment efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Chidamide, oral, 20 mg (4 tablets) each time, twice a week, D1-14.
Rituximab, 375 mg/m² IV, Cycle 1-4, Day 1.
Cyclophosphamide, 400 mg/m² IV, Cycle 1-4, Day 2.
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGProgression-free survival (PFS)
The time from study enrollment to the first documented disease progression or death from any cause, whichever occurs first.
Time frame: 24 months
Overall Response Rate (ORR)
To assess the Overall Response Rate (ORR) referred to Lugano 2014.
Time frame: 24 months
Duration of Response (DOR)
The duration from the first documentation of response (achievement of complete response or partial response) to the first unequivocal evidence of relapse or progression.
Time frame: 24 months
Complete Response Rate (CRR)
To assess the Complete Response Rate (CRR) referred to Lugano 2014.
Time frame: 24 months
Percentage of patients converting from PR/SD to CR/PR
Percentage of patients converting from PR/SD to CR/PR
Time frame: 24 months
Overall survival(OS)
Overall survival(OS) is defined as the time from the date of enrollment to the date of death from any cause.
Time frame: 24 months
Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment, assessed by NCI-CTCAE v5.0. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
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Doxorubicin, 25 mg/m² IV, Cycle 1-4, Day 2.
Vincristine, 1 mg/m² IV, Cycle 1-4, Day 2.
Prednisone, 40 mg/m² orally, Cycle 1-4, Days 1-5.
Chidamide, oral, 20 mg (4 tablets) each time, twice a week, D1-14. Rituximab, 375 mg/m² IV, once every 12 weeks. 21 days/cycle.
Time frame: 24 months