Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
- Conditions
- Diffuse Large B Cell Lymphoma
- Interventions
- Registration Number
- NCT02767674
- Brief 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 258
- Histologically confirmed diffuse large B cell lymphoma（With exception of Primary mediastinal large B cell lymphoma、Primary central nervous system lymphoma、HIV-related lymphoma);
- New-diagnosed and untreated;
- Age older than 80 years or older than 70 years with ECOG PS ≥ 2;
- Ann Arbor stage I to stage IV disease;
- Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.
- Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level, unless these abnormalities were related to the lymphoma;
- Poor bone-marrow reserve, defined as neutrophil count less than 1.5×10⁹/L or platelet count less than 75×10⁹/L, unless caused by bone marrow infiltration;
- Presence of Grade III nervous toxicity with two weeks;
- New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome、acute heart failure、severe ventricular arrhythmia
- Positive HIV, syphilis,HCV, or HBV virus load(HBV DNA)> 1×10'4copies/ml;
- CNS or meningeal involvement;
- Concomitant malignancy other than aggressive B cell lymphoma and need to Treat, with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma,or history of cancer more than 5 years;
- Concomitant with other hematologic diseases(such as leukemia, hemophilia primary myelofibrosis) which investigator it unsuitable to be enrolled into this clinical trial;
- Active and severe infectious diseases;
- Major surgery within three weeks;
- Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment.
- In any conditions which investigator considered ineligible for this study.
- Known sensitivity or allergy to investigational Product.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description R-miniCHOP Epirubicin Injectable Product 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) R-miniCHOP Cyclophosphamide 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) R-GemOx Gemcitabine Rituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days) R-GemOx Rituximab Rituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days) R-miniCHOP Vindesine 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) R-GemOx Oxaliplatin Rituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days) R-miniCHOP Rituximab 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) R-miniCHOP Prednisone 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 Measures
Name Time Method 2-year overall survival rate One year from the date of inclusion to date of death, irrespective of cause
- Secondary Outcome Measures
Name Time Method 2-year progression free survival rate One year from date of inclusion to date of progression, relapse, or death from any causePFS：from date of inclusion to date of progression, relapse, or death from any cause
overall response rate One year overall response rate after treated by R-GemOx or R-miniCHOP overall response rate after treated by R-GemOx or R-miniCHOP regimen
Trial Locations
- Locations (6)
Shandong Province Hospital
🇨🇳Jinan, Shandong, China
Tongji Medical College of HUST
🇨🇳Wuhan, Hubei, China
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
🇨🇳NanJing, Jiangsu, China
Sudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
QiLu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China