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New treatment option for Marginal Zone Lymphoma (MZL)
Official title Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve MZL.
ClinicalTrials.gov ID: NCT07372365
What this study is testing
What is Orelabrutinib Consolidation and Maintenance Therapy?
Orelabrutinib Consolidation and Maintenance Therapy is an investigational medicine, 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 study aims to explore a new treatment approach for patients with treatment-naive Marginal Zone Lymphoma (MZL). MZL is a type of slow-growing lymphoma that often affects older adults.
- 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
- Histologically confirmed CD20-positive marginal zone lymphoma (MZL) that has not received systemic therapy.
- MZL that has progressed or relapsed after prior local therapy (local therapy includes surgery, radiotherapy, Helicobacter pylori eradication, and...
- Age ≥18 years.
- Presence of an indication for treatment as determined by the investigator or patient's willingness to receive treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
You likely can't join if
- Underwent major surgery or severe trauma within 2 weeks prior to enrollment, or has not yet recovered from significant adverse effects.
- Has other malignancies currently or within the past 3 years, excluding those that have been cured (such as basal or squamous cell carcinoma of the...
- Has a history of stroke or intracranial hemorrhage within the past 3 months.
- Requires anticoagulation with warfarin or equivalent vitamin K antagonist.
- Has evidence of any comorbidities or medical conditions that may interfere with the conduct of the study or place the patient at significant risk...
- Is infected with human immunodeficiency virus, or has uncontrollable active hepatitis C virus or hepatitis B virus infection.
See the full eligibility criteria
- Histologically confirmed CD20-positive marginal zone lymphoma (MZL) that has not received systemic therapy.
- MZL that has progressed or relapsed after prior local therapy (local therapy includes surgery, radiotherapy, Helicobacter pylori eradication, and hepatitis C treatment) or is not amenable to local therapy.
- Age ≥18 years.
- Presence of an indication for treatment as determined by the investigator or patient's willingness to receive treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
- Adequate organ function as defined below:
- Hematology: Hemoglobin (HB) ≥60 g/L, platelets (PLT) ≥50×10⁹/L, neutrophils (NE) ≥1.0×10⁹/L (Note: people with cytopenia due to lymphoma bone marrow involvement are not restricted by this criterion).
- Cardiac: Left ventricular ejection fraction (LVEF) ≥50% as determined by echocardiogram.
- Renal: Creatinine ≤1.5×upper limit of normal (ULN) or creatinine clearance ≥30 ml/min.
- Hepatic: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3×ULN.
- Women of childbearing potential must have a negative pregnancy test. Both male and female patients must agree to use effective contraception during the treatment period and for 2 years thereafter.
- Life expectancy of more than 3 months.
- Voluntary provision of written informed consent.
- Underwent major surgery or severe trauma within 2 weeks prior to enrollment, or has not yet recovered from significant adverse effects.
- Has other malignancies currently or within the past 3 years, excluding those that have been cured (such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, prostatic intraepithelial neoplasia...
- Has a history of stroke or intracranial hemorrhage within the past 3 months.
- Requires anticoagulation with warfarin or equivalent vitamin K antagonist.
- Has evidence of any comorbidities or medical conditions that may interfere with the conduct of the study or place the patient at significant risk, including but not limited to severe cardiovascular disease (e.g., New...
- Is infected with human immunodeficiency virus, or has uncontrollable active hepatitis C virus or hepatitis B virus infection.
- Has uncontrollable active infection.
- Is pregnant or breastfeeding.
- Has any life-threatening disease, medical condition, or organ dysfunction that may jeopardize the safety of the patient, as determined by the investigator.
- Has any condition that may interfere with the absorption or metabolism of orelabrutinib or place the study results at unnecessary risk.
- Has central nervous system involvement by marginal zone lymphoma or evidence of disease transformation.
- Has any condition that the investigator judges may interfere with the patient's full participation in the study; any condition that poses significant risk to the patient; or any condition that may interfere with the...
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, 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 Suzhou, Jiangsu, 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.