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

Lenalidomide Combined With Rituximab as Front-line Therapy in Elderly Patients Aged Over 80 Years With Diffuse Large B Cell Lymphoma

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04622579

Acronym

R2DLBCL80

Enrollment

Registered

2020-11-10

Start date

2020-10-23

Completion date

2023-03-31

Last updated

2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age Over 80 Years, Diffuse Large B Cell Lymphoma

Keywords

lenalidomide

Brief 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.

Interventions

DRUGlenalidomide combined with rituximab

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

80 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
ORR	24 months	Overall response rate

Secondary

Measure	Time frame	Description
CR	24 months	Complete response
OS	from date of treatment until the date of death from any cause, assessed up to 5 years	Overall survival
PFS	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	Progression-free survival

Countries

China

Contacts

Primary ContactXinmiao Jiang

296260860@qq.com（+86）20-83827812

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026