Lenalidomide Based Immunotherapy in the Treatment of DLBCL

NCT03715296 | Unknown FDA Drug

• 1 other identifier: NHL-007
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  12 weeks

Secondary Outcomes (3)

• Progression free survival rate

  1 year

• Overall survival rate

  1 year

• Overall response rate

  12 weeks

Interventions

Lenalidomide 25mg DRUG

Lenalidomide 25mg/d PO d1-10 Plus Rituximab 375 mg/m2 IV d1, Cyclophosphamide 750mg/m2 IV d2, Doxorubicin 50mg/m2 IV d2, Vincristine 1.4 mg/m2 IV d2, Prednisone 60 mg/m2 PO d2-6 OR Ifosfamide 1500mg/m2/d iv d1-3, Carboplatin 5\*\[GFR(ml/min)+25\]mg/d iv d2, Etoposide 100mg/m2/d iv d1-3,

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

De novo DLBCL patients / Relapse Refractory DLBCL patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Weili Zhao, MD, PhD

CONTACT

64370045; Zhao.weili@yahoo.com

Zhong Zheng, MD

CONTACT

64370045; zheng_zhong89@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 23, 2018
• Study Start: October 18, 2018
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

CN (1)