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

Not Applicable

Recruiting

• Conditions: Diffuse Large B Cell Lymphoma
• Interventions: Drug: Lenalidomide

• Registration Number: NCT04432402
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-11
• Last Update Submitted: 2020-06-13
• Study Start: 2020-06-14
• Study First Posted: 2020-06-16
• Last Update Posted: 2020-06-16
• Primary Completion: 2022-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lenalidomide in Combination With R-GemOx	Lenalidomide	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

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicity	2 years	Dose limiting toxicity
Maximum tolerated dose	at the end of the first cycle of R2-GemOx (each cycle is 14 days)	Maximum tolerated dose

Secondary Outcome Measures

Name	Time	Method
overall survival	2 years	overall survival
progression-free survival	2 years	progression-free survival

Trial Locations

Locations (1)

The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital); 🇨🇳 Nanjing, Jiangsu, China