Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Inflammatory Agents

Anti-Infective Agents

Gemcitabine

Cyclophosphamide

Prednisone

Rituximab

Epirubicin

Oxaliplatin

Vindesine

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Antimetabolites

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Tubulin Modulators

Antimitotic Agents

Rituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days)

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)

Epirubicin Injectable Product

Huayuan Zhu, M.D., Ph.D.

Wei Xu, M.D., Ph.D.

Jianfeng Zou

Luqun Wang, M.D., Ph.D.

Xin Wang, M.D., Ph.D.

Weili Zhao, M.D., Ph.D.

Ye Guo, M.D., Ph.D.

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

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

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

from the date of inclusion to date of death, irrespective of cause

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 after treated by R-GemOx or R-miniCHOP overall response rate after treated by R-GemOx or R-miniCHOP regimen

The First Affiliated Hospital with Nanjing Medical University

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma	NCT02767674	Diffuse Large B...	Rituximab Gemcitabine Oxaliplatin Cyclophosphamid... Epirubicin Inje... Vindesine Prednisone	70 Years - 90 Years	The First Affiliated Hospital with Nanjing Medical University
Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma	NCT02767674	Diffuse Large B...	Rituximab Gemcitabine Oxaliplatin Cyclophosphamid... Epirubicin Inje... Vindesine Prednisone	70 Years - 90 Years	The First Affiliated Hospital with Nanjing Medical University

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