Lenalidomide Combined With Rituximab as Front-line Therapy in Elderly Patients Aged Over 80 Years With Diffuse Large B Cell Lymphoma
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- ORR
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 80 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: lenalidomide combined with rituximab (Drug)
Outcomes
Primary Outcomes
ORR
Time Frame: 24 months
Overall response rate
Secondary Outcomes
- CR(24 months)
- 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)
- OS(from date of treatment until the date of death from any cause, assessed up to 5 years)
Investigators
Wenyu Li
professor of medicine
Guangdong Provincial People's Hospital