To evaluate the efficacy and adverse effects of Azacitidine in combination with R-CHOP (ARCHOP) for the treatment of TP53-mutated previously untreated Diffuse large B-cell lymphoma
This is a Phase 2, open-label clinical trial study that aims to evaluate the efficacy (eg. Complete response, Overall Survival, Progression Free Survival) and adverse effects of Azacitidine in combination with R-CHOP (ARCHOP) for the treatment of TP53-mutated previously untreated Diffuse large B-cell lymphoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Specified dose on specified days: Azacitidine (A) 100mg subcutaneous d-1 to d-5 Rituximab (R) 375mg/m2 IV d0 Cyclophosphamide (C) 750mg/m2 IV d1 epirubicin (H) 75mg/m2 IV d1 or liposomal adriamycin (D) 25-30mg/m2 IV d1 Vincristine (O) 1.4mg/m2 (max 2mg) IV d1 Prednisone (P) 100mg orally d1-5
Bing Xu
Xiamen, Fujian, China
RECRUITINGComplete remission rate (CR)
CR is evaluated according to the Lugano criteria for lymphoma response.
Time frame: Up to 36 months
Partial remission rate (PR)
PR is evaluated according to the Lugano criteria for lymphoma response.
Time frame: Up to 36 months
Overall response rate (ORR)
Percentage of participants with best overall response of partial response (PR) and complete response (CR), using the Lugano criteria.
Time frame: Up to 36 months
Progression Free Survival (PFS)
The Kaplan-Meier method will be used to estimate the rate of PFS. PFS was defined as the time from the date of treatment initiation until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Time frame: Up to 36 months
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