Primary CNS Lymphoma Clinical Trial
Official title:
Rituximab, Methotrexate, Procarbazine, Vincristine, Lenalidomide (RL-MPV) Followed by BBC (BCNU, Busulfan, Cyclophosphamide) High-dose Chemotherapy With Auto-HCT and Maintenance Therapy With Nivolumab in Newly Diagnosed Primary CNS Lymphoma
The purpose of this study is to determine the efficacy and safety of the new treatment proposed in this study. Conducting a prospective study "CNS-2015" in patients with PDLBCL CNS made it possible to achieve 2-year EFS, DFS and OS of 83%, 83% and 88%, respectively. The presence of early relapses of the disease has now led to the need to find an alternative program for patients with PDLBCL CNS. In the new "CNS-2021" protocol, lenalidomide was included in the R-MPV program in order to intensify the induction stage. In the conditioning regimen, thiotepa was replaced by carmustine, due to its significant CNS bioavailability. In order to possibly prevent early relapses, an anti-PD-1 inhibitor (nivolumab) was used as maintenance therapy.
Patients will receive 4 cycles of RL-MPV (rituximab, methotrexate (MTX), procarbazine, vincristine, and lenalidomide (RL-MPV) as induction. The conditioning regimen prior to autologous blood stem cell transplantation includes high doses busulfan, thiotepa, and cyclophosphamide. After 3 months after autologous blood stem cell transplantation, maintenance therapy with nivolumab 3 mg/kg every 2 weeks for 6 months will be started.Patients will be out of the study at the time of death. All patients believe in the possibility of survival within 3 months throughout their lives. Survival status can be obtained by phone call, storage visit, or medical records (eg doctor's note/lab results from a clinic or storage visit). ;
| 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 |
NCT04627753 -
Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With PCNSL.
|
Phase 2 | |
| Recruiting |
NCT05518383 -
B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021
|
Phase 4 | |
| 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 |