Overview
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.
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.
Eligibility
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 1.5109/L or platelet count less than 75109/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 syndromeacute heart failuresevere 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