R2 in the Treatment of Follicular Lymphoma

Phase 2

• Conditions: Follicular Lymphoma
• Interventions: Drug: Revlimid

• Registration Number: NCT03715309
• Lead Sponsor: Ruijin Hospital

Brief Summary

Lenalidomide Based Immunotherapy in the Treatment of FL

Detailed Description

Lenalidomide Based Immunotherapy efficacy related molecular biomarker in follicular lymphoma

Study Timeline

• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-10-19
• Study First Posted: 2018-10-23
• Study Start: 2018-11-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-04
• Last Update Posted: 2019-07-08
• Primary Completion: 2020-11-01
• Study Completion: 2020-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

Patients diagnose as de novo or relapse refractory FL grade 1-3A .

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Revlimd	Revlimid	-

Primary Outcome Measures

Name	Time	Method
CR	12 weeks	Complete response rate

Secondary Outcome Measures

Name	Time	Method
PFS	1 year	Progression free survival rate
OS	1 year	Overall survival rate
ORR	12 weeks	Overall response rate

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China