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New treatment option for Marginal Zone Lymphoma(MZL)
Official title Orelabrutinib Combined With Rituximab as First-line Systemic Treatment for Marginal Zone Lymphoma
ClinicalTrials.gov ID: NCT07022223
What this study is testing
What is orelabrutinib combined with rituximab regimen?
orelabrutinib combined with rituximab regimen is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for marginal zone lymphoma(mzl).
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, prospective clinical study to evaluate the efficacy and safety of orelabrutinib combined with rituximab as first-line systemic treatment for 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;
- Histologically confirmed CD20-positive marginal zone lymphoma, including MALT, SMZL, and NMZL, with at least one lesion outside the spleen measuring...
- MZL that has progressed or relapsed after prior local therapy (including surgery, radiotherapy, anti-Helicobacter pylori treatment, and...
- ECOG performance status of 0-2;
- Presence of an indication for treatment as judged by the investigator (symptomatic, cytopenia, risk of end-organ damage, bulky disease, ongoing...
You likely can't join if
- Currently or previously having other malignancies, unless there is evidence of no recurrence or metastasis within the past 5 years after curative...
- Lymphoma involvement of the central nervous system or transformation to high-grade lymphoma;
- Non-hematological toxicities from prior anti-cancer treatments not recovered to ≤ Grade 1 (excluding alopecia);
- Presence of uncontrolled or significant cardiovascular disease, including:
- New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months before the...
- Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive...
See the full eligibility criteria
- Age ≥ 18 years, regardless of gender;
- Histologically confirmed CD20-positive marginal zone lymphoma, including MALT, SMZL, and NMZL, with at least one lesion outside the spleen measuring more than 1.5 cm in any axis;
- MZL that has progressed or relapsed after prior local therapy (including surgery, radiotherapy, anti-Helicobacter pylori treatment, and anti-hepatitis C treatment), or is not suitable for local therapy;
- ECOG performance status of 0-2;
- Presence of an indication for treatment as judged by the investigator (symptomatic, cytopenia, risk of end-organ damage, bulky disease, ongoing progression, or patient's desire for treatment);
- Adequate function of major organs, as follows:
- Hematology: Absolute neutrophil count ≥ 1.5×109/L, platelets ≥ 75×109/L, hemoglobin ≥ 75 g/L; if there is bone marrow involvement, absolute neutrophil count ≥ 1.0×109/L, platelets ≥ 50×109/L, hemoglobin ≥ 50 g/L;
- Biochemistry: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), AST or ALT ≤ 2 times ULN; serum creatinine ≤ 1.5 times ULN; serum amylase ≤ ULN;
- Coagulation: International normalized ratio (INR) ≤ 1.5 times ULN.
- Life expectancy of ≥ 3 months;
- Voluntary written informed consent obtained before screening for the trial.
- Currently or previously having other malignancies, unless there is evidence of no recurrence or metastasis within the past 5 years after curative treatment;
- Lymphoma involvement of the central nervous system or transformation to high-grade lymphoma;
- Non-hematological toxicities from prior anti-cancer treatments not recovered to ≤ Grade 1 (excluding alopecia);
- Presence of uncontrolled or significant cardiovascular disease, including:
- New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months before the first administration of the study drug, or arrhythmias requiring treatment...
- Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy);
- History of clinically significant QTc interval prolongation, or QTc interval \> 470 ms for females, \> 450 ms for males during the screening period;
- Symptomatic or medically treated coronary artery disease;
- Uncontrolled hypertension (defined as blood pressure not reaching target levels despite a reasonable and tolerable full dose of three or more antihypertensive drugs (including diuretics) for more than one month, or...
- Active bleeding within 2 months before screening, or currently taking anticoagulant drugs, or deemed by the investigator to have a clear tendency to bleed;
- Urine protein ≥ 2+, and 24-hour urine protein quantification ≥ 2 g/24 hours;
- History of deep vein thrombosis or pulmonary embolism within the past six months;
- History of organ transplantation or allogeneic bone marrow transplantation;
- Major surgery within 6 weeks before screening or minor surgery within 2 weeks before screening. Major surgery is defined as surgery using general anesthesia, but diagnostic endoscopy is not considered major surgery...
- Active infection or uncontrolled HBV (HBsAg positive and/or HBcAb positive with positive HBV DNA titer), HCV Ab positive, HIV/AIDS, or other severe infectious diseases;
- Currently having pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or other conditions that significantly affect pulmonary function;
- Previous treatment with BTK, BCR pathway inhibitors (such as PI3K, Syk), or BCL-2 inhibitors;
- Suitable and preparing for stem cell transplantation;
- Any psychiatric or cognitive impairment that may limit their understanding, execution of the informed consent form, and compliance with the study;
- people with drug abuse or alcoholism;
- Pregnant, breastfeeding women, and fertile people unwilling to use contraception;
- Need to continuously take drugs with moderate to severe inhibitory or strong inducing effects on cytochrome P450 CYP3A;
- Any other condition deemed by the investigator as unsuitable for participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
- Dongyang, China
- Hangzhou, China
- Huzhou, China
- Jiaxing, China
- Lishui, China
- Ningbo, China
- Quzhou, China
- Shaoxing, China
- Taizhou, China
- Wenzhou, China
- Yuyao, China
- Zhuji, 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 Hangzhou, Zhejiang, China; Dongyang, China; Hangzhou, China; Huzhou, China; Jiaxing, China; Lishui, China and 7 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.