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Clinical Trials/NCT04622579
NCT04622579UnknownPhase 2

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

Guangdong Provincial People's Hospital1 site in 1 country20 target enrollmentStarted: October 23, 2020Last updated:
Conditions
Interventions
Drugs

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

Experimental

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wenyu Li

professor of medicine

Guangdong Provincial People's Hospital

Study Sites (1)

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