Lenalidomide Combined With Rituximab as Front-line Therapy for DLBCL Patients Aged Over 80 Years (R2DLBCL80)

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Unknown; Phase 2

Conditions: Age Over 80 Years; Diffuse Large B Cell Lymphoma

Treatments: Drug: lenalidomide combined with rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT04622579

2020099H

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 80+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

lenalidomide combined with rituximab

Experimental group

Description:

Rituximab 375 mg/m2 i.v d1 q28d； Lenalidomide 10mg Po. d1-21 q28d. After 6 cycles, patients obtained CR or PR will continue with Lenalidomide maintenance till the 24th month.

Treatment:

Drug: lenalidomide combined with rituximab