NCT03715309
Unknown
Phase 2
R2 in the Treatment of Follicular Lymphoma Grade 1-3A
Overview
- Phase
- Phase 2
- Sponsor
- Ruijin Hospital
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- CR
Overview
Brief Summary
Lenalidomide Based Immunotherapy in the Treatment of FL
Detailed Description
Lenalidomide Based Immunotherapy efficacy related molecular biomarker in follicular lymphoma
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Revlimd
Experimental
Intervention: Revlimid (Drug)
Outcomes
Primary Outcomes
CR
Time Frame: 12 weeks
Complete response rate
Secondary Outcomes
- PFS(1 year)
- OS(1 year)
- ORR(12 weeks)
Investigators
Zhao Weili
Professor
Ruijin Hospital
Study Sites (1)
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