- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03715296
Lenalidomide Based Immunotherapy in the Treatment of DLBCL
Lenalidomide Based Immunotherapy Efficacy Related Molecular Biomarker in Diffuse Large B-cell Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Weili Zhao, MD, PhD
- Phone Number: 610707 64370045
- Email: zhao.weili@yahoo.com
Study Contact Backup
- Name: Zhong Zheng, MD
- Phone Number: 610707 64370045
- Email: zheng_zhong89@163.com
Study Locations
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
Other Study ID Numbers
- NHL-007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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