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New treatment option for Lymphoma
Official title Linperlisib Combination With Obinutuzumab Frontline Treatment of Marginal Zone Lymphoma Patients (MZL)
ClinicalTrials.gov ID: NCT06592170
What this study is testing
What is Linperlisib combination with obinutuzumab?
Linperlisib combination with obinutuzumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single arm, open label, national multicenter clinical study included patients with marginal zone lymphoma patients (MZL) , aim is to evaluate the efficacy and safety of first-line treatment with Linperlisib combined with obinutuzumab in patients with marginal zone lymphoma (MZL).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Age ≥ 18 years old, both male and female are acceptable; 2. Newly diagnosed marginal zone lymphoma confirmed by histopathology. Including...
- Hemoglobin (Hb) ≥ 90 g/L;
- Neutrophil count (ANC) ≥ 1.5 × 10\ 9/L;
- Platelets (PLT) ≥ 100 × 10\ 9/L; Biochemical examination:
- TBIL\<1.5 x upper limit of normal range (ULN);
You likely can't join if
- 1\. Patients who have received any targeted PI3K therapy before enrollment; 2. History of other primary invasive malignant tumors that have not been...
- There are multiple factors that can affect oral medication, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
- Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
- people with any severe and/or uncontrolled illnesses, including:
- Poor blood pressure control (systolic blood pressure ≥ 150mmHg 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...
See the full eligibility criteria
- 1\. Age ≥ 18 years old, both male and female are acceptable; 2. Newly diagnosed marginal zone lymphoma confirmed by histopathology. Including extranodal MZL, intranodal MZL, and splenic MZL; 3. There is at least one...
- Hemoglobin (Hb) ≥ 90 g/L;
- Neutrophil count (ANC) ≥ 1.5 × 10\ 9/L;
- Platelets (PLT) ≥ 100 × 10\ 9/L; Biochemical examination:
- TBIL\<1.5 x upper limit of normal range (ULN);
- Glutamate alanine aminotransferase (ALT) and Glutamate aspartate aminotransferase (AST) ≤ 2.5 × ULN;
- Serum creatinine (Cr) ≤ 1.25 × ULN or Endogenous creatinine clearance rate ≥ 60 mL/min (Cockcroft Gault formula); Coagulation function:
- International Normalized Ratio (INR) ≤ 1.5 × ULN;
- Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 9. Women who have the possibility of pregnancy must undergo a serum pregnancy test within 7 days before the first use of the test drug, and the result must be...
- 1\. Patients who have received any targeted PI3K therapy before enrollment; 2. History of other primary invasive malignant tumors that have not been relieved or have not been relieved for more than 3 years; 3. Patients...
- There are multiple factors that can affect oral medication, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
- Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
- people with any severe and/or uncontrolled illnesses, including:
- Poor blood pressure control (systolic blood pressure ≥ 150mmHg 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 [New York Heart Association (NYHA)...
- 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; History of interstitial pneumonia caused by COVID-19.
- Liver abnormalities:
- Decompensated cirrhosis (Child Pugh liver function rating B or C)
- Known history of liver disease with clinical significance. Including viral hepatitis, known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e. HBV DNA positive (\>2500 copies/mL or \>500IU/mL...
- Patients with renal failure requiring hemodialysis or peritoneal dialysis;
- people with uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage;
- Poor control of diabetes (FBG\>10mmol/L);
- Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification\>1.0g; 9. History of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency...
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changchun, Jilin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.