Research purpose: To evaluate the efficacy and safety of R-mini-MCOP in first-line treatment of primary treatment of diffuse large B-cell lymphoma (DLBCL) in elderly patients Experimental design: Single-arm, multicenter, prospective study
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Rituximab :375 mg/m2,ivgtt,d0; Mitoxantrone Liposome : The first dose level: 6mg/m2, ivgtt, d1; The second dose level: 8mg/m2, ivgtt, d1; The third dose level: 10mg/m2, ivgtt, d1; Cyclophosphamide :400 mg/m2,ivgtt,d1; Vincristine :1mg(,ivgtt,d1; Prednisone:40 mg/m2,po.,d1-5; Q3W
Complete response rate (CRR)
Complete response rate at the end of induction
Time frame: At the end of Cycle 2 (each cycle is 21 days)
Overall Response (CR+PR) Rate (ORR)
Overall Response (CR+PR) rate at the end of induction
Time frame: At the end of Cycle 2 (each cycle is 21 days)
Duration of response (DOR)
Time frame: From the date when criteria for response are met (CR or PR) until the date of progression or relapse. Patients without relapse or progression or death from other causes will be censored at their last assessment date (24 months from response date)
Progression-free survival (PFS)
Time frame: Time between the date of enrolment and the date of disease progression, relapse or death from any cause (12,24 months)
Overall Survival (OS)
Time frame: Time between the date of enrolment and the date of death from any cause (12,24, 36 and 48 months)
Event Free Survival (EFS)
Time frame: From the date of enrolment to the date of disease progression, relapse from CR, initiation of subsequent systemic anti-lymphoma therapy after the least 6 cycles of RI-CHOP (each cycle is 21 days), or death whichever occurs first (24, 36 and 48 months)
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