Trials / Unknown
UnknownNCT02767674
Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
Phase III,Randomized Controlled Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 258 (estimated)
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University · Academic / Other
- Sex
- All
- Age
- 70 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
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
Detailed description
Gemcitabine and Oxaliplatin(GemOx) shows effective activity in patients with relapsed diffuse large-cell lymphoma and other solid tumors. Our Previous study showed that two-weekly regimen of rituximab combined with GemOx regimen acheived comparable response rate to R-miniCHOP.The investigators therefore design this open-label,phase III and random trial to compared the safety and efficacy of R-Gemox versus R-miniCHOP as first-line treatment of elderly patients with diffuse large B cell lymphoma. Primary Outcome Measures: • 2-year overall survival rate Secondary Outcome Measures: * 2-year progression free survival rate * overall response rate * safety and toxicity Enrollment:258 Study Start Date: June 2016 Primary Completion Date: June 2019
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rituximab | 375 mg/m2 IVD day0 |
| DRUG | Gemcitabine | Gemcitabine 1 g/m2 IVD day 1 |
| DRUG | Oxaliplatin | Oxaliplatin 100 mg/m2 IVD day1 |
| DRUG | Cyclophosphamide | Cyclophosphamide 400 mg/m2 IVD d1 |
| DRUG | Epirubicin Injectable Product | Epirubicin 35 mg/m2 IVD d1 |
| DRUG | Vindesine | Vindesine 2 mg IVP d1 |
| DRUG | Prednisone | Prednisone 40mg/m2 PO d1-5 |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2016-05-10
- Last updated
- 2019-01-03
Locations
6 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02767674. Inclusion in this directory is not an endorsement.