The Efficacy and Safety of the RCMOP Sequential Therapy as a First-line Treatment for Patients With Intermediate-to-high Risk Diffuse Large B-cell Lymphoma Who Had Incomplete Remission.
NCT05990985 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2023-08-18
Summary
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.
Conditions
- Diffuse Large B-cell Lymphoma
Interventions
- DRUG
-
Mitoxantrone hydrochloride liposome injection
Mitoxantrone hydrochloride liposome injection (18 mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
- DRUG
-
RiTUXimab Injection
RiTUXimab Injection (375 mg/m\^2) will be administered by intravenous infusion on day 0 in a 3-week treatment cycle.
- DRUG
-
Cyclophosphamid
Cyclophosphamid (750 mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
- DRUG
-
Vincristine
Vincristine (1.4 mg/m\^2,maximum dose 2mg ) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
- DRUG
-
Prednisolone
Prednisolone (100mg/d) will be administered by intravenous infusion on day 1-5 in a 3-week treatment cycle.
Sponsors & Collaborators
-
CSPC Ouyi Pharmaceutical Co., Ltd.
collaborator INDUSTRY -
The First Hospital of Jilin University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-01
- Primary Completion
- 2024-08-01
- Completion
- 2026-08-01
Countries
- China
Study Locations
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