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

November 5, 2020 updated by: Wenyu Li, Guangdong Provincial People's Hospital

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xinmiao Jiang
  • Phone Number: （+86）20-83827812
  • Email: 296260860@qq.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

80 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 24 months
Overall response rate
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Collaborators

Guangzhou First People's Hospital
Foshan First People's Hospital
Huizhou Municipal Central Hospital
Shantou Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

November 5, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020099H

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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