A feasibility study to evaluate the utility of a drug (lenalidomide) for preventing recurence in patients with Primary central nervous system lymphoma.This study will use a drug called lenalidomide for 2 years after completion of standard treatment with aim of preventing recurences.

Phase 2

• Conditions: Health Condition 1: C858- Other specified types of non-Hodgkin lymphoma

• Registration Number: CTRI/2019/04/018546
• Lead Sponsor: Tata Memorial Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients with histologically proven PCNSL

2.Received methotrexate based induction therapy

3.Radiological Complete Remission, or unconfirmed complete remission (uCR)

4.Received consolidation therapy after achieving CR

5.Age > 18 years

6.PS <=2 after the completion of consolidation therapy

7.Adequate bone marrow function with absolute leukocytes > 2000/mm3, neutrophil count (ANC) > 1000/mm3, haemoglobin > 8 g/dl and platelets > 100 000/mm3

8.Adequate liver function with Serum SGOT/AST or SGPT/ALT < 3.0 X Upper Limit of Normal ULN ; bilirubin < 1.5 X LNS

9.Creatinineclearance >30 ml/min. Patients with calculated creatinine clearance between 30 and 60ml/min lenalidomide dose will be adjusted as follows (10mg once daily)

10.Able to take aspirin (75 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).

11.Able to understand the teratogenicity

12.Men and women of child bearing age should agree to use reliable contraception

13.Neuropathy of >= grade 2 severity

14.Able to understand and sign inform consent

Exclusion Criteria

1.HIV infection

2.Prior history of organ transplantation or other cause of severe immunodeficiency

3.History of heart disease and/or impaired cardiac function (ECG QTc >450 msec, congenital long qt syndrome, history of ventricular tachyarrhythmia, ventricular fibrillation, congestive heart failure nyha iii/iv, uncontrolled hypertension)

4.Pregnancy or breast feeding

5.Hypersensitivity to lenalidomide

6.Crcl <30ml/min

7.Patient at high risk for deep vein thrombosis not willing to take DVT prophylaxis

8.Active hepatitis B or C

9.Prior history of malignancies other than lymphoma within 3 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified