R±CEOP90 Versus R±CEOP75 in Newly Diagnosed Young Patients With Medium/High-risk DLBCL

Sponsor
FENG Ji-feng
Study ID
NCT03151044
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This clinical trial is designed to compare the efficacy and safety of R±CEOP90 containing high-dose epirubicin and R±CEOP75 containing standard epirubicin in newly diagnosed young patients with medium/high-risk diffuse large B-cell lymphoma. Half of the participants receive R±CEOP regimen containing 90mg/m2 epirubicin, while the other half of participants receive R±CEOP regimen containing 75mg/m2 epirubicin. Via exploring whether high-dose epirubicin shall achieve better efficacy and less toxicity, we hope to optimize current treatment choice for young patients with medium/high-risk diffuse large B-cell lymphoma.

Key Dates

Start date
Jul 31, 2016
Status verified
May 2017
Primary completion
Jul 31, 2017
Completion
Jul 31, 2017

Study Design

Enrollment
408 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EPI-90
    Participants in this arm shall be given high-dose Epirubicin Combined with CVP ± Rituximab for six 21-day cycles: High-dose Epirubicin 90mg/m2, i.v., Day 1; Cyclophosphamide 750mg/m2, i.v., Day 1; Vincristine 1.4mg/m2, i.v., Day 1; Prednisolone 100mg/m2, p.o., Day 1-5; Plus/not plus: Rituximab 375mg/m2, i.v., Day 0
  • Active Comparator: EPI-75
    Participants in this arm shall be given standard-dose Epirubicin, Combined with CVP ± Rituximab for six 21-day cycles: Standard-dose Epirubicin 75mg/m2, i.v., Day 1; Cyclophosphamide 750mg/m2, i.v., Day 1; Vincristine 1.4mg/m2, i.v., Day 1; Prednisolone 100mg/m2, p.o., Day 1-5; Plus/not plus: Rituximab 375mg/m2, i.v., Day 0

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: up to 2 years ]

Central Contacts

Related Studies