Linperlisib Plus Obinutuzumab and Venetoclax for Relapsed and Refractory Blastoid Variant of Mant… (NCT06324994) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. International normalized ratio (INR) ≤ 1.5 × ULN;
. Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR) according to the RECIST 1.1
Timeframe: At the end of Cycle 6 (each cycle is 28 days)
. 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 \[NYHA classification\];
. Active interstitial pneumonia or other chronic lung diseases leading to severe impairment of lung function, defined as FEV1 and DLCOc\<60% of normal predicted values;
. Liver abnormalities;
. Decompensated cirrhosis (Child Pugh liver function rating of B or C)