Lenalidomide in Combination With R-GemOx in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Treatments: Gemcitabine; Lenalidomide; Oxaliplatin

Criteria

Inclusion Criteria:

1. The histopathologic diagnosis was DLBCL (except primary mediastinal large B cell lymphoma, primary central lymphoma, HIV related lymphoma).

2. Age older than 70 years or older than 60 years with Eastern Cooperative Oncology Group(ECOG) performance status(PS) ≥ 2;

3. Expected survival ≥ 12 weeks;

4. At least a measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm);

5. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements;

6. All patients must agree to take effective contraceptive measures during the trial measures

Exclusion Criteria:

1. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons

2. Patients known to have varicella or herpes zoster virus infection

3. Previous exposure to any anti-tumor therapy

4. Poor hepatic and/or renal function, unless these abnormalities were related to the lymphoma

5. 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

6. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within past 12 months

7. 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

8. Central nervous system (CNS) or meningeal involvement

9. Known sensitivity or allergy to investigational product

10. Major surgery within three weeks

11. Patients receiving organ transplantation

12. 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

13. Presence of Grade III nervous toxicity within past two weeks

14. Active and severe infectious diseases

15. Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment

16. In any conditions which investigator considered ineligible for this study.

17. Histologic transformation