R-CMOP in Patients With Primary Diffuse Large B-cell Lymphoma

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT05777369
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    375 mg/m2, d0
  • Mitoxantrone hydrochloride liposome — DRUG
    18 mg/m2, d1
  • Cyclophosphamide — DRUG
    750 mg/m2, d1
  • Vincristine/Vindesine — DRUG
    Vincristine: 1.4 mg/m2, d1(The maximum dose was 2 mg) Vindesine: 3 mg/m2, d1
  • Prednisone — DRUG
    60 mg/m2, d1\~d5

Study Details

To evaluate the efficacy and safety of R-CMOP regimen based on mitoxantrone hydrochloride liposome injection in the treatment of newly diagnosed diffuse large B-cell lymphoma (DLBCL) based on cardiac function screening

Key Dates

Start date
Mar 31, 2023
Status verified
Mar 2023
Primary completion
Aug 31, 2023
Completion
Aug 31, 2024

Study Design

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

Arms

  • Experimental: R-CMOP
    R-CMOP：Rituximab, Cyclophosphamide, Mitoxantrone hydrochloride liposomes, Vincristine or Vindesine, Prednisone

Primary Outcome Measure

Objective Response Rate(ORR) [ Time Frame: up to 6 cycles of chemotherapy (each cycle is 21 days) ]

Central Contacts

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