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

Guangdong Provincial People's Hospital20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diffuse Large B Cell Lymphoma Age Over 80 Years

Interventions

lenalidomide combined with rituximabDRUG

lenalidomide and rituximab are dilivered as described, parameters concerning efficacy and safety are also obtained.

Eligibility

Sex: ALLMin age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Guangdong provincial people's hospital

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

ORR

Overall response rate

Time frame: 24 months

Secondary Outcomes

Complete response

Time frame: 24 months

Overall survival

Time frame: from date of treatment until the date of death from any cause, assessed up to 5 years

PFS

Progression-free survival

Time frame: from date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Central Contacts

Xinmiao Jiang

CONTACT

（+86）20-83827812 296260860@qq.com

Data from ClinicalTrials.gov

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