Lenalidomide Combined With Rituximab as Front-line Therapy for DLBCL Patients Aged Over 80 Years

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

Summary

About 40% of Diffuse large B cell lymphoma relapse or is refractory, age is a prognostic factor of DLBCL, as elderly patients are not capable to received standard treatment, the prognosis of elderly patients is poor especially those aged over 80 years. In this study,we aimed to investigate the safety and efficacy of the combination of lenalidomide and rituximab in elderly patients aged ≥ 80 years with untreated DLBCL.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong Provincial People's Hospital
• Collaborators: Foshan First People's Hospital; Guangzhou First People's Hospital; Huizhou Municipal Central Hospital; Shantou Central Hospital
• Treatments: Lenalidomide; Rituximab

Criteria

Inclusion Criteria:

1. Age≧80 years ;

2. ECOG score 0-2；

3. untreated with pathologically confirmed CD20+ DLBCL ;

4. expected life expectancy of ≥ 12 weeks;

5. capable of swallowing tablets;

6. GFR(by Cockcroft- Gault)≥30 ml/min;

7. can sign written informed consent to participate in the study.

Exclusion Criteria:

1. with CNS involvement;

2. with other malignancy (not including adequate-treated non-melanoma cutaneum carcinoma); patients with other cancer but disease-free for ≥5 years can enter this study;

3. with ≥ grade 2 peripheral neurophathy;

4. with cardiopathy including unstable angia or myocardial infarction over the past 8 weeks;

5. received live vaccine within 28 days.;

6. HIV-positive;

7. thrombosis ;

8. GFR<30 mL/min;

9. other conditions not suitable for rituximab or lenalidomide application.