enalidomide maintenance in Chronic Lymphocytic Leukemia
- Conditions
- Health Condition 1: null- Chronic Lymphocytic LeukemiaHealth Condition 2: C911- Chronic lymphocytic leukemia of B-cell type
- Registration Number
- CTRI/2018/07/014716
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Newly diagnosed cases of Chronic Lymphocytic Leukemia (International workshop on Chronic lymphocytic leukemia guidelines for the diagnosis and treatment of CLL) who have achieved at least a partial response (IWCLL guidelines) following completion (minimum 3 cycles) of first line therapy and have completed treatment at least 8 weeks and not more than 6 months prior to randomisation.
2.Patients of CLL who have relapsed after prior therapy and have achieved at least a partial response (IWCLL guidelines for the diagnosis and treatment of CLL) following completion (minimum 3 cycles) of second or third line therapy. Treatment should have been completed at least 8 weeks and not more than 6 months prior to randomisation.
3. Able to understand and provide an informed signed consent.
4. ECOG performance status must be less than or equal to 2
1. Active infection
2. Renal failure
3. Venous thromboembolism
4. Disease transformation (Richterâ??s transformation, Prolymphocytic leukemia)
5. Grade 2 or more neuropathy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy of Lenalidomide in prolonging progression free survival as compared to observation alone in Chronic Lymphocytic Leukemia.Timepoint: The study will be conducted over a period of 18 months from 1.1.2018 to 31.6.2019.
- Secondary Outcome Measures
Name Time Method 1. To assess the efficacy of Lenalidomide in delaying the time to next treatment as compared to observation alone. <br/ ><br> <br/ ><br>2. To study the adverse events related to Lenalidomide, when used as maintenance therapy in patients with CLL.Timepoint: The study will be conducted over a period of 18 months from 1.1.2018 to 31.6.2019.