Not Yet RecruitingPhase 2

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

China10 participantsStarted 2024-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Hemoglobin (Hb) ≥ 80 g/L;
✓. Neutrophils (ANC) ≥ 1.0 × 109/L;
✓. Platelet count (PLT) ≥ 75 × 109/L;
✓. TBIL\<1.5 × Upper limit of normal range (ULN);
✓. Glutamate alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;
✓. Serum creatinine (Cr) ≤ 1.25 × ULN or endogenous creatinine clearance rate ≥ 60 mL/min (Cockcroft Gault formula);
✓. International normalized ratio (INR) ≤ 1.5 × ULN;
✓. Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;

Exclusion criteria

✕. There are multiple factors that affect oral medication, such as inability to swallow, chronic diarrhea, and intestinal obstruction
✕. Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;
✕. Subjects with any severe and/or uncontrolled diseases, including:
✕. Poor blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
✕. Suffering from ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia \[including QTc ≥ 450ms (male), QTc ≥ 470ms (female)\], and ≥ grade 2 congestive heart failure \[NYHA classification\];

What they're measuring

Objective Response Rate (ORR) according to the RECIST 1.1

Timeframe: At the end of Cycle 6 (each cycle is 28 days)

Trial details

NCT IDNCT06324994

SponsorDalian Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-01

Contact for this trial

Xiuhua Sun, Doctor

+86 17709873631 3038668@vip.sina.com

View on ClinicalTrials.gov More Mantle Cell Lymphoma trials