A Study of R-mini-MCOP in the Treatment of Elderly, Previously Untreated DLBCL

Sponsor
Xiaohui He
Study ID
NCT06921044
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

Study Details

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

Key Dates

Start date
Apr 16, 2025
Status verified
Jan 2025
Primary completion
Feb 1, 2026
Completion
Mar 1, 2027

Study Design

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

Arms

  • Experimental: R-mini-MCOP
    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（Every 3 Weeks）

Primary Outcome Measure

Complete response rate （CRR） [ Time Frame: At the end of Cycle 2 (each cycle is 21 days) ]

Central Contacts

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