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New treatment option for Marginal Zone Lymphoma
Official title Exploratory Study of Orelabrutinib in the Treatment of Early-stage Untreated MZL
ClinicalTrials.gov ID: NCT07441993
What this study is testing
What is Orelabrutinib?
Orelabrutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for marginal zone 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, multicenter, prospective, phase II study. The primary objective is to assess the efficacy and safety of orelabrutinib in treatment-naïve patients with marginal zone lymphoma.
- 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
- Age ≥18 years, regardless of gender;
- Patients with histopathologically confirmed stage I/II marginal zone lymphoma;
- ECOG performance status score of 0-2;
- Major organ functions meeting the following criteria:
- Blood tests: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow involvement, ANC...
You likely can't join if
- Lymphoma involving the central nervous system or transformation to high-grade;
- Uncontrolled or significant cardiovascular diseases, including:
- New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the...
- Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive...
- History of clinically significant QTc interval prolongation, or QTc interval \>470 ms for females or \>450 ms for males at screening;
- people with symptomatic coronary artery disease requiring medication;
See the full eligibility criteria
- Age ≥18 years, regardless of gender;
- Patients with histopathologically confirmed stage I/II marginal zone lymphoma;
- ECOG performance status score of 0-2;
- Major organ functions meeting the following criteria:
- Blood tests: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow involvement, ANC ≥1.0×10\^9/L, platelets ≥50×10\^9/L, hemoglobin ≥50g/L;
- Blood biochemistry: Total bilirubin ≤1.5×ULN, AST or ALT ≤2×ULN; serum creatinine ≤1.5×ULN;
- Coagulation function: International normalized ratio (INR) ≤1.5×ULN;
- Expected survival time ≥12 months;
- Voluntary written informed consent signed before trial screening.
- Lymphoma involving the central nervous system or transformation to high-grade;
- Uncontrolled or significant cardiovascular diseases, including:
- New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first dose of the study drug, or arrhythmia requiring treatment at...
- Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, or unclassified cardiomyopathy);
- History of clinically significant QTc interval prolongation, or QTc interval \>470 ms for females or \>450 ms for males at screening;
- people with symptomatic coronary artery disease requiring medication;
- Poorly controlled hypertension (failure to achieve target blood pressure after at least one month of lifestyle modification and treatment with three or more antihypertensive drugs, including diuretics, at maximally...
- Active bleeding within 2 months prior to screening, or current use of anticoagulants, or investigator-determined clear bleeding tendency;
- History of deep vein thrombosis or pulmonary embolism within the past six months;
- Urine protein ≥2+ and 24-hour urine protein quantification ≥2 g/24 hours;
- Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or people with total gastrectomy;
- Current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or other conditions affecting lung function;
- Pregnant or breastfeeding women, or people of childbearing potential unwilling to use contraception;
- Continuous use of drugs with moderate to strong cytochrome P450 CYP3A inhibition or strong induction effects;
- Other conditions deemed by the investigator as unsuitable for participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Xiangyang, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Nantong, Jiangsu, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Jinan, Shandong, China
- Beijing, China
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 Guangzhou, Guangdong, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Xiangyang, Hubei, China; Changsha, Hunan, China; Nanjing, Jiangsu, China and 6 more location(s). 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.