A clinical study was conducted to evaluate the efficacy and safety of the RCMOP regimen sequential therapy as a first-line treatment for patients with intermediate-to-high risk diffuse large B-cell lymphoma who had incomplete remission.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Mitoxantrone hydrochloride liposome injection (18 mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
RiTUXimab Injection (375 mg/m\^2) will be administered by intravenous infusion on day 0 in a 3-week treatment cycle.
Cyclophosphamid (750 mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Objective response rate (ORR)
To evaluate the efficacy of anti-tumor
Time frame: At the end of cycle 2, At the end of cycle 4, (each cycle is 21 days)
Complete response rate (CRR)
To evaluate the efficacy of anti-tumor
Time frame: At the end of cycle 2, At the end of cycle 4; (each cycle is 21 days)
Duration of Response (DOR)
To evaluate the efficacy of anti-tumor
Time frame: CR or PR up to data cut-off (up to approximately 2 years)
Progression-free survival (PFS)
To evaluate the efficacy of anti-tumor
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Overall survival (OS)
To evaluate the efficacy of anti-tumor
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Treatment emergent adverse events (TEAEs)
The incidence and severity of adverse events assessed by CTCAE v5.0
Time frame: The first dose up to 21 or 28 days after the last dose
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Vincristine (1.4 mg/m\^2,maximum dose 2mg ) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
Prednisolone (100mg/d) will be administered by intravenous infusion on day 1-5 in a 3-week treatment cycle.