Trial of R-GemOx Regimen in Previously Untreated Elderly Patients With DLBCL.

Study Overview
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Brief Summary
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The purpose of this study is to investigate efficacy and safety of GemOx(Gemcitabine and Oxaliplatin) combination with rituximab(R) as first-line treatment of elderly patients with DLBCL

Detailed Description
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Previous studies showed that the combination of rituximab, gemcitabine and oxaliplatin (R-GemOx) achieved high efficacy with a low toxicity profile in relapsed and refractory DLBCL. This regimen might be considered a putative treatment option for elderly patients. To our knowledge, the efficacy and safety of R-GemOx when given as first-line therapy in elderly patients with DLBCL remains unknown. The investigators therefore developed a two-weekly regimen of rituximab combined with GemOx regimen as first line treatment in elderly DLBCL and investigate its efficacy and safety. Primary Outcome Measures: overall response rate Secondary Outcome Measures: progression free survival overall survival safety and toxicity Enrollment: 60 Study Start Date: August 2012 Primary Completion Date: Dec 2015

Official Title
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A Prospective, Single-arm, Open-label, Phase 2 Study to Evaluate Efficacy and Safety of R-GemOx Regimen as First-line Treatment in Elderly Patients With Diffuse Large B-cell Lymphoma (DLBCL).

Conditions
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Diffuse Large B-cell Lymphoma

Intervention / Treatment
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* Drug: R-GemOx


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Histologically confirmed CD20-positive DLBCL (The germinal center B-cell like (GCB) / non-GCB subtype was determined by immunohistochemistry in paraffin-embedded tissue using CD10, BCL6 and MUM1 protein markers based on Hans's algorithm); New-diagnosed and untreated; Age older than 70 years or older than 60 years with ECOG PS ≥2; Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: Poor hepatic or renal function, defined as total serum bilirubin, transaminases or creatinine over two times of the upper limit of normal concentration; Poor cardiac function greater than Grade II according to New York Heart Association Functional Classification; Presence of Grade III nervous toxicity over two weeks; Hepatitis B virus (HBV) load (HBV DNA) more than 1×105 copies/ml; Concomitant malignancy other than DLBCL requiring treatment; Concomitant with other hematologic diseases (such as leukemia, hemophilia, primary myelofibrosis) which is unsuitable to be enrolled into this clinical trial; Contraindication to any drug in this regimen; Active and severe infectious diseases, such as severe pheumonia or septicaemia; Major surgery within three weeks; Any medical, psychological or social conditions which might interfere with the investigators' assessment In any conditions which investigator considered ineligible for this study.

Ages Eligible for Study
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Minimum Age: 60 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab+Gemcitabine+oxaliplatin (R-GemOx)<br>Rituximab: 375 mg/m2 IV day1, Gemcitabine 1g/m2 IV day 2, oxaliplatin 100mg/m2 IV day2(every 14 days) | Drug: R-GemOx<br>* Rituximab Gemcitabine Oxaliplatin<br>* Other names: Oxaliplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate | overall response rate after 3 cycles and at the end of R-GemOx regimen. | at the end of 3 cycles and 6 cycles of R-GemOx regimen(each cycle is 14 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | from date of inclusion to date of progression, relapse from response, or death from any cause or last follow-up. | Two-year | 
| overall survival | from the date of inclusion to date of death, irrespective of cause or last follow-up. | Two-year | 
| The incidence and severity of adverse events | All the treatment related adverse events was evaluated according to common terminology criteria adverse events(CTCAE) version 4.0 | Up to 30 days following the last dose of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rituximab, Gemcitabine, Oxaliplatin, Diffuse large B-cell lymphoma