Efficacy and Safety of Lenalidomide in Combination With R-GemOx in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
Overview
- Phase
- Not Applicable
- Intervention
- Lenalidomide
- Conditions
- Diffuse Large B Cell Lymphoma
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- Dose limiting toxicity
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
WEI XU
Professor
The First Affiliated Hospital with Nanjing Medical University
Eligibility Criteria
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
Arms & Interventions
Lenalidomide in Combination With R-GemOx
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
Intervention: Lenalidomide
Outcomes
Primary Outcomes
Dose limiting toxicity
Time Frame: 2 years
Dose limiting toxicity
Maximum tolerated dose
Time Frame: at the end of the first cycle of R2-GemOx (each cycle is 14 days)
Maximum tolerated dose
Secondary Outcomes
- overall survival(2 years)
- progression-free survival(2 years)