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Clinical Trials/CTRI/2019/04/018546
CTRI/2019/04/018546
Recruiting
Phase 2

Phase 2 Study To Evaluate The Efficacy Of Lenalidomide Maintenance In Primary CNS Lymphoma. - PRoCLAIM

Tata Memorial Center0 sites0 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Tata Memorial Center
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Tata Memorial Center

Eligibility 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 \<\=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).

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

Outcomes

Primary Outcomes

Not specified

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