Health Condition 1: C858- Other specified types of non-Hodgkin lymphoma
Conditions
Interventions
Intervention1: Lenalidomide, High dose methotrexate and Rituximab based induction therapy: Tab. Lenalidomide 25 mg 21 days every 28 days for 4 cycles
Methotrexate 8 gm/m2 day 1 and day 14 every 28 day
Sponsors
Tata Memorial Center
Government funding agency
Pharmaceutical Industry
Eligibility
Inclusion criteria
Inclusion criteria: Patients with histologically proven PCNSL Age > 18 years ECOG PS At least one bi-dimensionally measurable target lesion on MRI Adequate bone marrow function with absolute leukocytes > 2000/mm3, neutrophil count (ANC) > 1000/mm3, haemoglobin > 8 g/dl and platelets > 100 000/mm3 Adequate liver function with Serum SGOT/AST or SGPT/ALT Creatinine clearance more than 60 ml/min Men and women of child bearing age should agree to use reliable contraceptive Neuropathy of >= grade 2 severity
Exclusion criteria
Exclusion criteria: HIV infection Prior history of organ transplantation or other cause of severe immunodeficiency History of heart disease and/or impaired cardiac function (ECG QTc >450msec, congenital long QT syndrome, history of ventricular tachyarrhythmia, ventricular fibrillation, congestive heart failure nyha iii/iv, uncontrolled hypertension) Pregnancy or breast feeding Hypersensitivity to lenalidomide Active hepatitis B and C Prior history of malignancies within 3 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate to induction chemotherapyTimepoint: At the end of induction i.e. 4 months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse effect profile of induction chemotherapy 2. 2 year progression free survival and overall survival 3. Evaluation of quality of life 4. Overall response rates 5. Overall compliance to treatmentTimepoint: 2 years | — |
Countries
India
Contacts
Public ContactDr Bhausaheb Bagal
Tata Memorial Center
Outcome results
None listed