Lenalidomide Based Immunotherapy in the Treatment of DLBCL

July 4, 2019 updated by: Zhao Weili, Ruijin Hospital

Lenalidomide Based Immunotherapy Efficacy Related Molecular Biomarker in Diffuse Large B-cell Lymphoma

This study is to evaluate the efficacy related molecular biomarker of Lenalidomide plus RCHOP or RICE in the treatment of de novo or Refractory and Relapsed DLBCL patients

Study Overview

Status

Unknown

Conditions

Diffuse Large B Cell Lymphoma

Intervention / Treatment

Drug: Lenalidomide 25mg

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Locations

China
- Shanghai
  - Shanghai, Shanghai, China, 200025
    - Recruiting
    - Ruijin Hospital
    - Contact:
      
      Weili ZHAO, MD, PhD
      
      Phone Number: 610707 86-21-64370045
      
      Email: zhao.weili@yahoo.com
    - Contact:
      
      Shu CHENG, MD, PhD
      
      Phone Number: 665251 86-21-64370045
      
      Email: orenge@medmail.com.cn
    - Sub-Investigator:
      
      Shu CHENG, MD, PhD

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

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

De novo DLBCL patients / Relapse Refractory DLBCL patients

Description

Inclusion Criteria:

Histologically diagnosed as diffuse large b-cell lymphoma and may provide a desirable lymph node tissue sample (10 paraffin sections or rolls) or lymph node biopsy sample (15 paraffin sections or rolls)

Previously treated with Lenalidomide plus RCHOP regimen in de novo DLBCL or Lenalidomide plus RICE regimen in relapse refractory DLBCL.

No history of stem cell transplantation.

Written informed consent.

Exclusion Criteria:

Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.

Clinically significant active infection.

Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.

Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.

Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.

Patients who are pregnant or breast-feeding.

HIV infection.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete response rate Time Frame: 12 weeks	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival rate Time Frame: 1 year	1 year
Progression free survival rate Time Frame: 1 year	1 year
Overall response rate Time Frame: 12 weeks	12 weeks

Collaborators and Investigators

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

Sponsor

Ruijin 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 18, 2018

Primary Completion (Anticipated)

September 15, 2020

Study Completion (Anticipated)

September 15, 2020

Study Registration Dates

First Submitted

October 19, 2018

First Submitted That Met QC Criteria