Ignite Creation Date:
2024-05-06 @ 5:46 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05425654
Status:
RECRUITING
Last Update Posted:
2022-06-21
First Post:
2022-06-08
Brief Title:
RL-MPV Followed by BBC HCT Using Autologous Stem Cells and Maintenance Therapy With Nivolumab for Newly Diagnosed PCNSL
Sponsor:
National Research Center for Hematology Russia
Organization:
National Research Center for Hematology Russia
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 mgkg every 2 weeks for 6 months will be startedPatients 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 doctors notelab results from a clinic or storage visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None