Lenalidomide Based Immunotherapy in the Treatment of DLBCL

• Sponsor: Ruijin Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03715296
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 22.9
• Patients Per Site Per Month: 8.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B Cell Lymphoma	Drug: Lenalidomide 25mg

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Lenalidomide Based Immunotherapy Efficacy Related Molecular Biomarker in Diffuse Large B-cell Lymphoma
• Actual Study Start Date: Oct 18, 2018
• Anticipated Primary Completion Date: Sep 15, 2020
• Anticipated Study Completion Date: Sep 15, 2020

Outcome Measures

Primary Outcome Measures

1. Complete response rate [12 weeks]

Secondary Outcome Measures

1. Progression free survival rate [1 year]

2. Overall survival rate [1 year]

3. Overall response rate [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruijin hospital	Shanghai	Shanghai	China	200025

Sponsors and Collaborators

• Ruijin Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhao Weili, Professor, Ruijin Hospital
• ClinicalTrials.gov Identifier: NCT03715296
• Other Study ID Numbers: NHL-007
• First Posted: Oct 23, 2018
• Last Update Posted: Jul 8, 2019
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lenalidomide

Study Results

No Results Posted as of Jul 8, 2019