Actively Recruiting
Linperlisib Combination With Obinutuzumab Frontline Treatment of Marginal Zone Lymphoma Patients (MZL)
Led by The First Hospital of Jilin University · Updated on 2024-09-19
35
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Linperlisib Combination With Obinutuzumab Frontline Treatment of Marginal Zone Lymphoma Patients (MZL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Newly diagnosed marginal zone lymphoma confirmed by histopathology, including extranodal, intranodal, or splenic MZL
- At least one measurable lesion: lymph node lesion longer diameter over 1.5 cm or extra lymph node lesion longer diameter over 1 cm
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Expected survival of at least 12 weeks
- No prior anti-tumor treatment
- Adequate bone marrow and organ function
- Screening laboratory tests within 7 days before enrollment meeting specified blood counts, liver, kidney, and coagulation criteria
- Negative pregnancy test for women of childbearing potential within 7 days before treatment start and agreement to use effective contraception during study and for 1 year after last dose
- Male participants with partners of childbearing potential must agree to surgical sterilization or effective contraception during study and for 1 year after last dose
- Voluntary informed consent with ability to comply and cooperate with follow-up
You will not qualify if you...
- Prior targeted PI3K therapy
- History of other primary invasive malignant tumors not resolved or unresolved for more than 3 years
- Central nervous system involvement (meninges or brain parenchyma)
- Known allergy to study drugs
- Participation in other drug clinical trials within 4 weeks before study start
- Pregnant or breastfeeding women
- Active infections except tumor-related B symptoms and fever
- Conditions affecting oral medication intake such as inability to swallow, chronic diarrhea, or intestinal obstruction
- History of psychotropic drug abuse or mental disorders preventing cessation
- Severe or uncontrolled illnesses including poor blood pressure control (systolic ≥150 mmHg or diastolic ≥100 mmHg), significant heart diseases, chronic lung diseases with severe impairment, liver abnormalities including decompensated cirrhosis or active viral hepatitis, renal failure requiring dialysis
- Uncontrolled pleural, pericardial effusion, or ascites needing repeated drainage
- Poorly controlled diabetes (fasting blood glucose >10 mmol/L)
- Significant proteinuria (urine protein ≥++ and 24-hour urine protein >1.0 g)
- History of immunodeficiency including HIV positive or organ transplantation
- Any other diseases posing serious safety risks or affecting study completion as judged by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Hospital of Jilin University
Changchun, Jilin, China, 130000
Actively Recruiting
Research Team
O
Ou Bai Ou Bai, MD/PHD, The First Hospital of Jilin University, MD/PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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