The efficacy of Lenalidomide - Rituximab (LR) vs Bendamustine â??Rituximab (BR) in untreated follicularlymphoma
Phase 3
- Conditions
- Health Condition 1: null- Treatment naive follicular lymphoma
- Registration Number
- CTRI/2016/05/006904
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 74
Inclusion Criteria
1. Age >=18 years at diagnosis
2. low grade lymphoma-FL
3. ECOG PS â?? 0-2
4. Stage-II â?? IV ( if symptomatic)
5. Normal organ function - creatinine clearance >60ml/min; SGOT and SG PT < 2.5times of
Exclusion Criteria
1. CD 20 negative NHL
2. Grade 3b Follicular Lymphoma
3. H/o previous malignancy within the past 5 years, uncontrolled serious systemic illness, HIV infection, or active hepatitis B or C infection
4. Not willing for enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoints <br/ ><br>-Complete response rate will be assessed according to IWG criteria 7. Secondary endpoints: <br/ ><br>- Overall response rate <br/ ><br>- Safety and toxicityTimepoint: Jan 2016- Jan 2018
- Secondary Outcome Measures
Name Time Method Secondary endpoints: <br/ ><br>- Overall response rateTimepoint: Jan 2016- Jan 2018;Secondary endpoints: <br/ ><br>- Safety and toxicityTimepoint: Jan 2016- Jan 2018