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.

Sponsor
The First Hospital of Jilin University
Study ID
NCT05990985
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mitoxantrone hydrochloride liposome injection — DRUG
    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 — DRUG
    RiTUXimab Injection (375 mg/m\^2) will be administered by intravenous infusion on day 0 in a 3-week treatment cycle.
  • Cyclophosphamid — DRUG
    Cyclophosphamid (750 mg/m\^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
  • Vincristine — DRUG
    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 — DRUG
    Prednisolone (100mg/d) will be administered by intravenous infusion on day 1-5 in a 3-week treatment cycle.

Study Details

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.

Key Dates

Start date
Sep 1, 2023
Status verified
Aug 2023
Primary completion
Aug 1, 2024
Completion
Aug 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RCMOP
    RiTUXimab Injection+Cyclophosphamid+Mitoxantrone hydrochloride liposome injection+Vincristine+Prednisolone, 4 cycles of treatment

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: At the end of cycle 2, At the end of cycle 4, (each cycle is 21 days) ]

Central Contacts

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