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

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04432402
• Other study ID #: 2019-SR-443
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2020
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Li Wang, M.D
• Phone: +862568136034
• Email: lilyw7878[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Lenalidomide
Lenalidomide: 10mg?15mg?20mg?25mg qd PO day 1-7, Rituximab: 375 mg/m2 IV day0, Gemcitabine :1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1 (every 14 days as a cycle)

Locations

Country	Name	City	State
China	The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose	Maximum tolerated dose	at the end of the first cycle of R2-GemOx (each cycle is 14 days)
Primary	Dose limiting toxicity	Dose limiting toxicity	28 days
Primary	Dose limiting toxicity	Dose limiting toxicity	2 years
Secondary	progression-free survival	progression-free survival	2 years
Secondary	overall survival	overall survival	2 years