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 Study To Evaluate The Efficacy Of Lenalidomide Maintenance In Primary CNS Lymphoma. - PRoCLAIM

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/04/018546

Enrollment

Registered

2019-04-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Lenalidomide: Patients with primary CNS Lymphoma achieving complete remission on standard therapy will be given maintenance lenalidomide at a starting dose of 15 mg per day for 21 days

Eligibility

Inclusion criteria

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 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 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

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 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

Design outcomes

Primary

Measure	Time frame
Progression free survivalTimepoint: 2 years	—

Secondary

Measure	Time frame
Overall survivalTimepoint: 2 years;Quality of lifeTimepoint: 2 years;Safety (Grade 3 and 4 side effects)Timepoint: 2 years	—

Countries

India

Contacts

Public ContactDr Bhausaheb Bagal

Tata Memorial Center

bagalbp@gmail.com02224177210

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026