- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03715309
R2 in the Treatment of Follicular Lymphoma
R2 in the Treatment of Follicular Lymphoma Grade 1-3A
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Weili Zhao
- Phone Number: 610707 +86 64370045
- Email: Zhao.weili@yahoo.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200025
- Recruiting
- Ruijin Hospital
-
Contact:
- Zhong Zheng
- Phone Number: 64370045
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Revlimd
|
Revlimid 25mg PO d1-10 Plus Rituximab 375 mg/m2 IV d0
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CR
Time Frame: 12 weeks
|
Complete response rate
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: 1 year
|
Progression free survival rate
|
1 year
|
OS
Time Frame: 1 year
|
Overall survival rate
|
1 year
|
ORR
Time Frame: 12 weeks
|
Overall response rate
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Follicular
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
Other Study ID Numbers
- RJ-R2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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