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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diffuse Large B Cell Lymphoma, Age Over 80 Years

Intervention / Treatment
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* Drug: lenalidomide combined with rituximab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lenalidomide combined with rituximab<br>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<br>* lenalidomide and rituximab are dilivered as described, parameters concerning efficacy and safety are also obtained.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Overall response rate | 24 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lenalidomide