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

Study Overview
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Brief Summary
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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
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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

Official Title
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Phase III,Randomized Controlled Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma

Conditions
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Diffuse Large B Cell Lymphoma

Intervention / Treatment
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* Drug: Rituximab
* Drug: Gemcitabine
* Drug: Oxaliplatin
* Drug: Cyclophosphamide
* Drug: Epirubicin Injectable Product
* Drug: Vindesine
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R-GemOx<br>Rituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days) | Drug: Rituximab<br>* 375 mg/m2 IVD day0<br>Drug: Gemcitabine<br>* Gemcitabine 1 g/m2 IVD day 1<br>Drug: Oxaliplatin<br>* Oxaliplatin 100 mg/m2 IVD day1<br>|
| Active Comparator: R-miniCHOP<br>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) | Drug: Rituximab<br>* 375 mg/m2 IVD day0<br>Drug: Cyclophosphamide<br>* Cyclophosphamide 400 mg/m2 IVD d1<br>Drug: Epirubicin Injectable Product<br>* Epirubicin 35 mg/m2 IVD d1<br>Drug: Vindesine<br>* Vindesine 2 mg IVP d1<br>Drug: Prednisone<br>* Prednisone 40mg/m2 PO d1-5<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year overall survival rate | from the date of inclusion to date of death, irrespective of cause | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year progression free survival rate | 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 | One year | 
| overall response rate | overall response rate after treated by R-GemOx or R-miniCHOP overall response rate after treated by R-GemOx or R-miniCHOP regimen | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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R-Gemox, R-miniCHOP, elderly patients with diffuse large B cell lymphoma