Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-02-23 @ 1:52 PM
Study NCT ID:
NCT06454266
Status:
COMPLETED
Last Update Posted:
2024-07-30
First Post:
2024-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First-line Treatment of PCNSL With the Combination of Orelabrutinib, Rituximab, and Methotrexate (ORM Regimen)
Sponsor:
Ningbo No. 1 Hospital
Organization:
Study Overview
Official Title:
Exploration of the Efficacy and Safety of Orelabrutinib Combined With Rituximab and Methotrexate (ORM Regimen) in the First-line Treatment of Primary Central Nervous System Lymphoma
Status:
COMPLETED
Status Verified Date:
2024-07
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:
Exploring the efficacy and safety of first-line treatment of primary central nervous system lymphoma with the combination of orelabrutinib, rituximab and methotrexate (ORM regimen).
Detailed Description:
This is an open, single arm, single center clinical study. Untreated primary central nervous system lymphoma patients sign an informed consent form and meet all inclusion criteria. The subjects received treatment with the ORM regimen every 21 days for a total of 6 cycles.
The main purpose is to evaluate the anti-tumor activity (ORR) of the first-line treatment of primary central nervous system lymphoma with the combination of otinib, rituximab, and methotrexate (ORM regimen).
Secondary purpose:
1. Evaluate the safety and tolerability of first-line treatment of primary central nervous system lymphoma with the combination of otinib, rituximab, and methotrexate (ORM regimen).
2. Other efficacy evaluations of the first-line treatment of primary central nervous system lymphoma with the combination of otinib, rituximab, and methotrexate (ORM regimen) include CR, DOR, DCR, and PFS.
3. Evaluate the peripheral blood and cerebrospinal fluid pharmacokinetic characteristics of obrutinib and methotrexate.
The exploratory purpose is to investigate the relationship between the dynamic changes of cerebrospinal fluid ctDNA before and after treatment and the efficacy and prognosis.
The main purpose is to evaluate the anti-tumor activity (ORR) of the first-line treatment of primary central nervous system lymphoma with the combination of otinib, rituximab, and methotrexate (ORM regimen).
Secondary purpose:
1. Evaluate the safety and tolerability of first-line treatment of primary central nervous system lymphoma with the combination of otinib, rituximab, and methotrexate (ORM regimen).
2. Other efficacy evaluations of the first-line treatment of primary central nervous system lymphoma with the combination of otinib, rituximab, and methotrexate (ORM regimen) include CR, DOR, DCR, and PFS.
3. Evaluate the peripheral blood and cerebrospinal fluid pharmacokinetic characteristics of obrutinib and methotrexate.
The exploratory purpose is to investigate the relationship between the dynamic changes of cerebrospinal fluid ctDNA before and after treatment and the efficacy and prognosis.
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?: