None listed
Conditions
Interventions
Drug : this study is single arm study. Patients who achieve PR or CR after induction chemotherapy (or consolidation chemotherapy) will receive lenalidomide 25mg PO daily day 1 to day 21 per 28 days cy
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion 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. - All female patients of childbering age must agree to have two negative pregnancy test within 10-14 days and 24hrs before commencing lenalidomide and use two reliable methods of contraception simultaneously or practice completete abstinence from any heterosexual intercouse during the following time period related to this study; 1) 1) for at least 28 days before starting study; 2) while participating in the study; 3) dose interruptions; and 4) for at least 28 days after study treatment discontinuation. The two methods of reliable contraception must include one highly effective method and one additional effective method to prevent pregnancy, not plan on conceiving children during or within 6 months following lenalidomide 6. Male patients, even if surgically sterilized (i.e. status post-vasectomy), who: a. Agree to practice effective barrier contraception during the entire study treatment period and through 28 days after the last dose of study treatment, OR b. Agree to completely abstain from heterosexual intercourse, AND c. Must also adhere to the guidelines of the lenalidomide pregnancy prevention and risk management program 7. patients who can take oral medications 8. Written informed consent in accordance with federal, local and institutional guidelines
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival at 2 year;overall survival;response rate;safety | — |
Countries
Korea, Republic of
Contacts
Public ContactJin Seok Kim
Yonsei University Health System, Severance Hospital
Outcome results
None listed