Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06324994
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-09
Brief Title:
Linperlisib Plus Obinutuzumab and Venetoclax for Relapsed and Refractory Blastoid Variant of Mantle Cell Lymphoma
Sponsor:
Dalian Medical University
Organization:
Dalian Medical University
Study Overview
Official Title:
A Single-arm Open-label National Multi-center Clinical Study of Linperlisib in Combination With Obinutuzumab and Venetoclax in the Treatment of Relapsed and Refractory Blastoid Variant of Mantle Cell Lymphoma RR BV-MCL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
This is a single arm open label national multicenter clinical study included patients with relapsed and refractory blastoid variant of mantle cell lymphoma RR BV-MCL aiming to evaluate the efficacy of a chemotherapy free triple therapy of PI3K inhibitor Linperlisib combined with anti-CD20 monoclonal antibody Obinutuzumab and BCL-2 inhibitor Venetoclax in RR BV-MCL patients
Detailed Description:
This is a single arm open label national multicenter clinical study that included 10 cases of relapsed and refractory blastoid variant of mantle cell lymphoma RR BV-MCL The aim was to evaluate the efficacy of a chemotherapy free triple therapy consisting of PI3K inhibitor Linperlisib combined with anti-CD20 monoclonal antibody Obinutuzumab and BCL-2 inhibitor Venetoclax in patients with RR BV-MCL It is divided into a combined induction period and a maintenance treatment period All enrolled patients receive the following combined treatment combined induction period Linperlisib 80 mg orally pre - and post meal once a day Obinutuzumab 1000 mgdose intravenous infusion administered on the first day 1st cycle is 1 8 15 days Up to 6 cycles administration cycle can be adjusted according to clinical treatment conditions Venetoclax increase from 40mg 100mg and 200mg to 400mg within 4 weeks followed by a treatment cycle of 400mg orally once a day Starting from the third cycle Every 28 days there are a total of 6 cycles Maintenance treatment period Linperlisib 80 mg oral both before and after meals once a day Venetoclax 400 mg oral once daily Cycle every 28 days After 6 cycles of combined treatment the efficacy is evaluated according to the Lugano2014 standard If complete remission CR or partial remission PR is achieved maintenance treatment with a combination of 80 mg of linprixate and 400 mg of vinclair is administered every 28 days until disease progression intolerable toxicity or other reasons lead to discontinuation If it is stable disease SD and progressive disease PD patients will be excluded from the group The main research endpoint is Objective Response Rate ORR Secondary study endpoints include progression free survival PFS Overall survival OS duration of response DOR and safety incidence and severity of adverse events AE and severe adverse events SAE Safety incidence and severity of adverse events AE and severe adverse events SAE
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