It's a prospective, single arm, open label phase II clinical trial, in which the safety and efficacy of Chidamide plus R-CHOP regimen is accessed in de novo DLBCL patients, who have received 2 courses of R-CHOP but only achieved PR or whose MRD tests for ctDNA revealed positive results. abbreviation: R-CHOP: the chemo-therapy regimen composed of Rituximab, cyclophosphoamide, etoposide, vincristine and prednisone. PR: partial remission; MRD:minimal residual disease;
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Patients will receive 2 courses of Chidamide+ R-CHOP regimen, the way of administration and dosage of the medicine used in the trial is as follows: Rituximab 375mg//m2, ivgtt,d1;CTX 750mg/m2, ivgtt,d2;EPI 70mg/m2, ivgtt,d2;VCR 1.4 mg/m2, ivgtt, d2; Pred 60 mg/m2,PO, d2-6; Chidamide 20mg/d,d1、4、8、11、14、18;one cycle every 21 days;
The first affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGcomplete remission rate
complete remission rate after treated by Chidamide+ R-CHOP regimen
Time frame: every 3 months until 30 months after the last patient's enrollment
progression free survival
from date of inclusion to date of progression, relapse, or death from any cause
Time frame: from the day of treatment to the date of first documented progression,up to 30 months after the last patient's enrollment
overall survival
from the date of inclusion to date of death, irrespective of cause
Time frame: 30 months after the last patient's enrollment
adverse events
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Time frame: from the date of first cycle of treatment to 30 months after last patient's enrollment
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