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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Combined induction period: Linprixate: 80 mg, oral (pre - and post meal), once a day; Otuzumab: 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); Vineclavone: 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), one cycle every 28 days, for a total of 6 cycles。 Maintenance treatment period: Linprixate: 80 mg, oral (both before and after meals), once a day; Vinecala: 400 mg, oral, once daily; Cycle every 28 days.
The Second Hospital Dalian Medical University
Dalian, Liaoning, China
Objective Response Rate (ORR) according to the RECIST 1.1
The ORR rate of patients with Linperlisib in combination with Obinutuzumab and Venetoclax for relapsed and refractory blastoid variant of mantle cell lymphom
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Progression-free survival (PFS)
The time from the start of clinical trials to the occurrence (in any aspect) of tumor progression or death due to any reason
Time frame: From date of enrollment until the date of first documented progression and loss of follow-up or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival (OS)
The time from the start of tumor treatment to (for any reason) death.
Time frame: From date of enrollment until the date of first date of death from any cause, expected evaluation period of up to 48 months
Duration of Overall Response (DOR)
The time from the first judgment of complete remission (CR) or partial remission (PR) to the discovery of disease progression (PD).
Time frame: From date of the time from the first assessment of the tumor as CR or PR to the first assessment as PD (Progressive Disease) or death from any cause,assessed up to 24 months
Adverse event (AE)
Refers to adverse medical events that occur in the clinical trial process of the subject
Time frame: Record any adverse events starting from the first medication use until the end of the safety follow-up period. The evaluation period shall not exceed 24 months.
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