Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT02767674
Phase
PHASE3
Status
Unknown

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
70 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    375 mg/m2 IVD day0
  • Gemcitabine — DRUG
    Gemcitabine 1 g/m2 IVD day 1
  • Oxaliplatin — DRUG
    Oxaliplatin 100 mg/m2 IVD day1
  • Cyclophosphamide — DRUG
    Cyclophosphamide 400 mg/m2 IVD d1
  • Epirubicin Injectable Product — DRUG
    Epirubicin 35 mg/m2 IVD d1
  • Vindesine — DRUG
    Vindesine 2 mg IVP d1
  • Prednisone — DRUG
    Prednisone 40mg/m2 PO d1-5

Study Details

The purpose of this study is to investigate efficacy and safety of R-GemOx Versus R-miniCHOP as first-line treatment of elderly patients with Diffuse large B cell lymphoma

Key Dates

Start date
May 31, 2016
Status verified
Jan 2019
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020

Study Design

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

Arms

  • Experimental: R-GemOx
    Rituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days)
  • Active Comparator: R-miniCHOP
    Rituximab, 375 mg/m2 IV d0 Cyclophosphamide 400 mg/m2 IV d1 Epirubicin 35 mg/m2 IV d1 vindesine 2 mg IVP d1 Prednisone 40mg/m2 PO d1-5(every 21 days a cycle)

Primary Outcome Measure

2-year overall survival rate [ Time Frame: One year ]

Central Contacts

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