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

Sponsor

Guangdong Provincial People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04622579

Collaborator

Guangzhou First People's Hospital (Other), Foshan First People's Hospital (Other), Huizhou Municipal Central Hospital (Other), Shantou Central Hospital (Other)

Enrollment

Location

Arm

29.2

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B Cell Lymphoma Age Over 80 Years	Drug: lenalidomide combined with rituximab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 23, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: lenalidomide combined with rituximab lenalidomide and rituximab are dilivered as described, parameters concerning efficacy and safety are also obtained.

Arm

Intervention/Treatment

Experimental: 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.

Drug: lenalidomide combined with rituximab

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

Outcome Measures

Primary Outcome Measures

ORR [24 months]
Overall response rate

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

80 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age≧80 years ;
ECOG score 0-2；
untreated with pathologically conﬁrmed CD20+ DLBCL ;
expected life expectancy of ≥ 12 weeks;
capable of swallowing tablets;
GFR(by Cockcroft- Gault)≥30 ml/min;
can sign written informed consent to participate in the study.

Exclusion Criteria:

with CNS involvement;
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;
with ≥ grade 2 peripheral neurophathy;
with cardiopathy including unstable angia or myocardial infarction over the past 8 weeks;
received live vaccine within 28 days.;
HIV-positive;
thrombosis ;
GFR<30 mL/min;
other conditions not suitable for rituximab or lenalidomide application.