Linperlisib Plus Obinutuzumab and Venetoclax for Relapsed and Refractory Blastoid Variant of Mantle Cell Lymphoma.

Sponsor
Dalian Medical University
Study ID
NCT06324994
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Linperlisib in combination with Obinutuzumab and Venetoclax — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 1, 2024
Status verified
Mar 2024
Primary completion
May 1, 2025
Completion
Dec 1, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: cohort 1
    Patients with relapsed refractory lymphoblastic mantle cell lymphoma who have not previously received treatment with PI3K inhibitors and BCL-2 inhibitors

Primary Outcome Measure

Objective Response Rate (ORR) according to the RECIST 1.1 [ Time Frame: At the end of Cycle 6 (each cycle is 28 days) ]

Central Contacts

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