Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT06324994
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 (R/R 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 R/R 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 (R/R 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 R/R 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 mg/dose, 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:
NCT06324994
Study Brief:
Protocol Section:
NCT06324994