Status:
UNKNOWN
Lenalidomide in Combination With R-GemOx in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
60+ years
Phase:
NA
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 safet...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04432402
Start Date
June 14 2020
End Date
December 31 2024
Last Update
June 16 2020
Active Locations (1)
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1
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Nanjing, Jiangsu, China, 210029