Health Condition 1: null- Chronic Lymphocytic Leukemia Health Condition 2: C911- Chronic lymphocytic leukemia of B-cell type
Conditions
Interventions
Intervention1: Lenalidomide: Lenalidomide will be administered orally at a starting dose of 5 mg every alternate day for 21 days in a 28 day cycle. If this dose is well tolerated, it will be increased
Sponsors
PGIMER Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1. Active infection 2. Renal failure 3. Venous thromboembolism 4. Disease transformation (Richterâ??s transformation, Prolymphocytic leukemia) 5. Grade 2 or more neuropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. To assess the efficacy of Lenalidomide in delaying the time to next treatment as compared to observation alone. 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. | — |
Countries
India
Contacts
Public ContactDr Nishant Jindal
Post Graduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed