KCT0007409
Not yet recruiting
未知
An Open-label, Phase 2 Study of lenalidomide Maintenance in Transplant-Ineligible Patients with Primary Central Nervous System Lymphoma
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Yonsei University Health System, Severance Hospital
- Enrollment
- 35
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. newly diagnosed, histologically confirmed, transplant ineligible primary CNS lymphoma
- •2\. patients with partial response following induction chemotherapy.
- •(consolidation therapy is planned, but it can be omitted in patietns who cannot receive high dose chemotherapy)
- •3\. patients who are over 60 years, or less than 60 years, who can not receive autologous hematopoietic stem cell transplantaion
- •4\. adequate laboratory values
- •\- creatitine clearance \= 30mL/min
- •\- total bilirubin \= 1\.5 x upper limit of the normal range.
- •\- ALT/AST \= 3 x ULN.
- •5\. female pateints of childbering potentisl, if she aggree to
- •\- follow the lenalidomide risk management progrem.
Exclusion Criteria
- •1\. other subtypes except diffuse large B\-cell lymphoma
- •2\. secondary CNS lymphoma
- •3\. history of human immunodeficiency virus (HIV)
- •4\. patients who could not take the oral agnets
- •5\. patients who have plan to autologous stem cell transplantation
- •6\. pregnant or breastfeeding females, or women of childbearing potential who did not use adequate contraceptives
- •7\. allery to chemotherapeutic agents using this study
- •8\. kidney diseaes on hemodialysis or peritoneal dialysis
- •9\. uncontrolled life threatening infection
- •10\. allery or hypersnesitivity ro lenalidomide
Outcomes
Primary Outcomes
Not specified
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