Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554561
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
A Study of Pomadomide in Combination With Rituximab and Methotrexate for Newly-diagnosed Primary Central Nervous System Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Safety and Efficacy of Pomadomide in Combination With Rituximab and Methotrexate for Newly-diagnosed Primary Central Nervous System Lymphoma A Prospective Multicenter Phase III Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective multicenter single-arm open Phase IbII clinical study to explore the safety and efficacy of pomadomide in combination with rituximab and methotrexate RPM in newly diagnosed primary central nervous system lymphoma PCNSL subjects The Phase I study is a dose escalation study in which rituximab and methotrexate are fixed doses and pomadomide is set into 3 dose groups 3mgd 4mgd and 5mgd In strict accordance with the 33 dose escalation principle 3-6 subjects are to be recruited in each dose group and each subject is to be observed for 1 cycle after treatment to determine MTD Phase II study RP2D is planned to be determined based on the Phase Ib study with an additional 25 active participants enrolled to further evaluate efficacy and safety Subjects with initial treatment of PCNSL who met the inclusionexclusion criteria were screened and after signing the informed consent letter they received 4 courses of PRM regimen The patients achieving CR or PR were consolidated by autologous transplantation consolidation regimen or the original regimen for 2 courses and then were given pomadomide maintenance therapy for 12 cycles Follow-ups should be taken up to the first 3 years
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None