Clinical Trials Logo

Clinical Trial Summary

- 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).


Clinical Trial Description

-As described, standard treatment for patients with primary central nervous system lymphoma is not yet based on a high level of evidence, and studies on consolidation therapy for elderly patients who cannot transplant this disease are very limited. Based on the Korea National Cancer Incidence Database, about 100 to 150 cases of primary central nervous system lymphoma are diagnosed per year in Korea, and 15 to 30% of them are judged to experience recurrence. Rituximab and lenalidomide (RR) are drugs that are expected to play a role in patients with primary central nervous system lymphoma who have already refractory or relapsed as described above, but there is a big hurdle that the number of patients is limited. Since then, it has not been studied as consolidation therapy in elderly or non-transplantable patients. Therefore, the present investigators attempted to confirm the efficacy and safety of lenalidomide/rituximab maintenance therapy in patients with primary central nervous system lymphoma who received high-dose methotrexate-containing anticancer drug, but could not receive consolidation therapy with autograft. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04627753
Study type Interventional
Source Samsung Medical Center
Contact Seok Jin Kim, MD, PhD
Phone 82-2-3410-1766
Email kstwoh@skku.edu
Status Recruiting
Phase Phase 2
Start date November 2, 2020
Completion date November 2, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05036564 - Diagnosis; Objective RespOnse; THErApy N/A
Recruiting NCT03569995 - [CREMA]Combination of R-M Followed by R-A in Elderly Patients With Primary CNS Lymphoma Phase 2
Recruiting NCT05518383 - B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 Phase 4
Recruiting NCT05425654 - RL-MPV Followed by BBC HCT Using Autologous Stem Cells and Maintenance Therapy With Nivolumab for Newly Diagnosed PCNSL Phase 2
Terminated NCT04073147 - Venetoclax and Obinutuzumab for Relapsed/Refractory Primary CNS Lymphoma Phase 1
Active, not recruiting NCT04443829 - Immunotherapy Using CAR T-cells to Target CD19 for Relapsed/Refractory CD19+ Primary CNS Lymphoma Phase 1
Recruiting NCT04006561 - Prospective Neurobehavioral Functions in Newly-diagnosed Patients With Primary CNS Lymphoma Treated With Hyperfractionated Conformal Whole-brain Radiation Therapy Plus Simultaneous Integrated Boost
Recruiting NCT04656431 - Feasibility of Acquiring Hyperpolarized Imaging in Patients With Primary CNS Lymphoma Phase 1
Active, not recruiting NCT04464200 - 19(T2)28z1xx Chimeric Antigen Receptor (CAR) T Cells in People With B-Cell Cancers Phase 1
Recruiting NCT02934204 - Temozolomide in Treatment of Patients With Primary Central Nervous System Lymphoma Phase 2
Recruiting NCT04947319 - Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study) Phase 2
Active, not recruiting NCT04134117 - Tisagenlecleucel In Primary CNS Lymphoma Phase 1
Withdrawn NCT03212807 - Study Of Durvalumab and Lenalidomide In R/R EBV Associated DLBCL Subtypes, Primary CNS And Testicular DLBCL Phase 2