Back to resultsR2 in the Treatment of Follicular Lymphoma
Primary Purpose
Follicular Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Revlimid
Sponsored by
About this trial
This is an interventional treatment trial for Follicular Lymphoma
Eligibility Criteria
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.
Sites / Locations
- Ruijin HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Revlimd
Arm Description
Outcomes
Primary Outcome Measures
CR
Complete response rate
Secondary Outcome Measures
PFS
Progression free survival rate
OS
Overall survival rate
ORR
Overall response rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03715309
Brief Title
R2 in the Treatment of Follicular Lymphoma
Official Title
R2 in the Treatment of Follicular Lymphoma Grade 1-3A
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
November 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Lenalidomide Based Immunotherapy in the Treatment of FL
Detailed Description
Lenalidomide Based Immunotherapy efficacy related molecular biomarker in follicular lymphoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Revlimd
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Revlimid
Other Intervention Name(s)
lenalidomide
Intervention Description
Revlimid 25mg PO d1-10 Plus Rituximab 375 mg/m2 IV d0
Primary Outcome Measure Information:
Title
CR
Description
Complete response rate
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
PFS
Description
Progression free survival rate
Time Frame
1 year
Title
OS
Description
Overall survival rate
Time Frame
1 year
Title
ORR
Description
Overall response rate
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weili Zhao
Phone
+86 64370045
Ext
610707
Email
Zhao.weili@yahoo.com
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhong Zheng
Phone
64370045
12. IPD Sharing Statement
Learn more about this trial
R2 in the Treatment of Follicular Lymphoma
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