Lenalidomide in Combination With R-GemOx 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 Lenalidomide in combination with R-GemOx 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. The purpose of this study is to investigate efficacy and safety of Lenalidomide in combination with R-GemOx as first-line treatment of elderly patients with Diffuse large B cell lymphoma.

Official Title
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Efficacy and Safety of Lenalidomide in Combination With R-GemOx 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: Lenalidomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The histopathologic diagnosis was DLBCL (except primary mediastinal large B cell lymphoma, primary central lymphoma, HIV related lymphoma). Age older than 70 years or older than 60 years with Eastern Cooperative Oncology Group(ECOG) performance status(PS) ≥ 2; Expected survival ≥ 12 weeks; At least a measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm); Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements; All patients must agree to take effective contraceptive measures during the trial measures Exclusion Criteria: Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons Patients known to have varicella or herpes zoster virus infection Previous exposure to any anti-tumor therapy Poor hepatic and/or renal function, 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 History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within past 12 months 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 Central nervous system (CNS) or meningeal involvement Known sensitivity or allergy to investigational product Major surgery within three weeks Patients receiving organ transplantation Patients with secondary tumour, excluding cured (5 years without relapse) in situ Non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer, Gastrointestinal intramucous carcinoma and breast cancer Presence of Grade III nervous toxicity within past two weeks Active and severe infectious diseases 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. Histologic transformation

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: Lenalidomide in Combination With R-GemOx<br>Lenalidomide 10mg、15mg、20mg、25mg qd PO d1-7 Rituximab 375mg/m2 ivd d0 Gemcitabine 1g/m2 ivd d1 Oxaliplatin 100mg/m2 ivd d1 every14 days as a cycle | Drug: Lenalidomide<br>* Lenalidomide: 10mg、15mg、20mg、25mg qd PO day 1-7, Rituximab: 375 mg/m2 IV day0, Gemcitabine :1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1 (every 14 days as a cycle)<br>* Other names: Rituximab, Gemcitabine, oxaliplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose | Maximum tolerated dose | at the end of the first cycle of R2-GemOx (each cycle is 14 days) | 
| Dose limiting toxicity | Dose limiting toxicity | 28 days | 
| Dose limiting toxicity | Dose limiting toxicity | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | progression-free survival | 2 years | 
| overall survival | overall survival | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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R-Gemox, Lenalidomide