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

Nanjing Medical University

Status: Enrolling

Conditions: Diffuse Large B Cell Lymphoma

Treatments: Drug: Lenalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT04432402

2019-SR-443

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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124 participants in 1 patient group

Lenalidomide in Combination With R-GemOx

Experimental group

Description:

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

Treatment:

Drug: Lenalidomide