Lenalidomide Based Immunotherapy in the Treatment of DLBCL

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03715296
• Other study ID #: NHL-007
• Status: Recruiting
• Start date: October 18, 2018
• Est. completion date: September 15, 2020

Study information

• Verified date: July 2019
• Source: Ruijin Hospital
• Contact: Weili Zhao, MD, PhD
• Phone: 64370045
• Email: Zhao.weili[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Lenalidomide 25mg
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,

Locations

Country	Name	City	State
China	Ruijin hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate		12 weeks
Secondary	Progression free survival rate		1 year
Secondary	Overall survival rate		1 year
Secondary	Overall response rate		12 weeks