Phase II Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With Primary CNS Diffuse Large B-cell Lymphoma (Nickname: Lemon-C Study)
* After standard treatment of primary central nervous system lymphoma (PCNSL), high-dose methotrexate induction therapy, and consolidation therapy, most patients reach complete remission, but within the first 6 months, 35-60% of patients refractory to treatment or experience relapse during the first treatment. * The progression-free survival (PFS) period of relapsed patients is 2.2 months (0-29.6 months), and the survival period is reported as 3.5 months (0-29.6 months). After relapse, the majority of patients die within 2-4 months due to neurologic deterioration * Consolidation therapy after induction therapy includes whole-brain radiation therapy, high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation (auto-SCT), and high-dose chemotherapy alone. * However, the median age of the inducing patient is 65 years, and more than half of the patients who are unable to transplant autologous hematopoietic stem cells (auto-SCT) after induction therapy account for more than half. * Therefore, we intend to conduct a study to evaluate the efficacy and safety of maintenance therapy for rituximab and lenalidomide as one of the consolidation therapies for patients with primary central nervous system lymphoma (PCNSL).
• Those who have been diagnosed with histopathological primary central nervous system lymphoma and who have completed standard chemotherapy for induction of remission of primary central nervous system lymphoma have reached a complete or partial response.
• Those who are unable to transplant autologous hematopoietic stem cells for the following reasons
‣ If you are 65 years of age or older or if you are judged to have a weak systemic condition before receiving high-dose chemotherapy
⁃ Refusal of autologous hematopoietic stem cell transplantation after high-dose chemotherapy
• Adequate laboratory functional values
‣ Absolute neutrophil count ≥ 1000/ul
⁃ Platelet count ≥ 50,000/ul
⁃ Hemoglobin ≥ 9.0 g/dL
⁃ Serum calcium ≤ 12.0mg/dL
⁃ Serum creatinine ≤ 1.5 X UNL
⁃ AST/ALT ≤ 2.5 X UNL
⁃ Total bilirubin ≤ 1.5 X UNL
• Hepatitis B patients with combination of prophylactic antiviral therapy
• ECOG PS 0-2
• Those who can take oral medication
• Written informed consent under institutional guidelines.
• Female patients of child-bearing potential (FCBP) must have two negative pregnancy tests (sensitivity of at least 25 mIU/mL) prior to starting lenalidomide. The first pregnancy test must be performed within 10 to 14 days prior to the start of lenalidomide, and the second pregnancy test must be performed within 24 hours prior to the start of lenalidomide.
• Effective method of contraception should be used during and for 28 days following the last dose of the drug
• \- FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
⁃ Male patients must use an effective barrier method of contraception during study and 28 days following the last dose if sexually active with a FCBP.