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

NCT03151044 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2017-05-12

No results posted yet for this study

Summary

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.

Conditions

  • Diffuse Large B-cell Lymphoma

Interventions

DRUG

High-dose Epirubicin Combined with CVP ± Rituximab

Experimental group shall be given high-dose Epirubicin (90mg/m2) combined with standard-dose Cyclophosphamide (750mg/m2), Vincristine (1.4mg/m2) and Prednisolone (100mg/m2) ± Rituximab

DRUG

Standard-dose Epirubicin Combined with CVP ± Rituximab

Active comparator group shall be given standard-dose Epirubicin and standard-dose Cyclophosphamide (750mg/m2), Vincristine (1.4mg/m2) and Prednisolone (100mg/m2) ± Rituximab

Sponsors & Collaborators

  • Chinese Anti-Cancer Association

    collaborator OTHER

  • FENG Ji-feng

    lead OTHER

Principal Investigators

  • Jifeng Feng, M.D. · Jiangsu Cancer Institute and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03151044 on ClinicalTrials.gov