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

Phase 2

• Conditions: Age Over 80 Years; Diffuse Large B Cell Lymphoma
• Interventions: Drug: lenalidomide combined with rituximab

• Registration Number: NCT04622579
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-23
• Status Verified: 2020-11
• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-05
• Last Update Submitted: 2020-11-05
• Study First Posted: 2020-11-10
• Last Update Posted: 2020-11-10
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lenalidomide combined with rituximab	lenalidomide combined with rituximab	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.

Primary Outcome Measures

Name	Time	Method
ORR	24 months	Overall response rate

Secondary Outcome Measures

Name	Time	Method
CR	24 months	Complete response
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
OS	from date of treatment until the date of death from any cause, assessed up to 5 years	Overall survival

Trial Locations

Locations (1)

Guangdong provincial people's hospital; 🇨🇳 Guangzhou, Guangdong, China