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New treatment option for Extranodal Marginal Zone B-cell Lymphoma
Official title The Treatment of Ocular Adnexal Extranodal Marginal Zone B-cell Lymphoma by Orelabrutinib and Radiotherapy
ClinicalTrials.gov ID: NCT06503276
What this study is testing
What is Orelabrutinib?
Orelabrutinib is an investigational medicine, being studied as a potential treatment for extranodal marginal zone b-cell 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
- Extranodal marginal zone B-cell lymphoma (EMZL) is the most common lymphoma of the ocular adnexa (OA), accounting for approximately 60%. As a special part of the body, there is no consensus on the optimal treatment strategy for OA-EMZL.
- 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 to 75
You may be able to join if
- 1: Male or female, aged 18-75 years.
- 2: Newly diagnosed patients with Marginal Zone B-cell lymphoma of ocular adnexa confirmed by surgical biopsy, with early Ann Arbor stage (stage I/II)...
- 3: Laboratory tests prior to admission must meet the following criteria: white blood cell count ≥3.0x10\^9/L, absolute neutrophil count ≥1.5...
- Liver function: transaminase levels≤3 times the upper limit of normal, bilirubin levels ≤1.5 times the upper limit of normal.
- Serum creatinine clearance ≥30 mL/min. Myocardial enzymes \< 2 times the upper limit of normal (same age). ECOG score 0-2.
You likely can't join if
- 1: Pregnant or lactating women, and women of childbearing potential who refuse to use contraceptive measures.
- 2: Inability to swallow, chronic diarrhea, or intestinal obstruction, or any condition that affects drug use and absorption.
- 3: Pre-trial treatment: Use of drugs that significantly affect the P450 metabolic enzyme pathway within 2 weeks before the screening period.
- Current use of cyclosporins or fibrates. Participation in other clinical studies and use of investigational drugs within 28 days prior to the...
- The need to use concomitant drugs that may prolong QTc or induce tip torsion ventricular TdP, in addition to antimicrobials used as standard care to...
- 4: Evidence of current uncontrolled cardiovascular disease, including: Uncontrolled high blood pressure. Uncontrolled arrhythmia. Symptomatic...
See the full eligibility criteria
- 1: Male or female, aged 18-75 years.
- 2: Newly diagnosed patients with Marginal Zone B-cell lymphoma of ocular adnexa confirmed by surgical biopsy, with early Ann Arbor stage (stage I/II) and evaluable lesions (\> 1cm) on imaging.
- 3: Laboratory tests prior to admission must meet the following criteria: white blood cell count ≥3.0x10\^9/L, absolute neutrophil count ≥1.5 x10\^9/L, hemoglobin ≥90g /L, platelets ≥75x 10\^9/L.
- Liver function: transaminase levels≤3 times the upper limit of normal, bilirubin levels ≤1.5 times the upper limit of normal.
- Serum creatinine clearance ≥30 mL/min. Myocardial enzymes \< 2 times the upper limit of normal (same age). ECOG score 0-2.
- 4: All people must provide informed consent and voluntarily sign the written informed consent form themselves or through their legal representatives before participating in the study.
- 1: Pregnant or lactating women, and women of childbearing potential who refuse to use contraceptive measures.
- 2: Inability to swallow, chronic diarrhea, or intestinal obstruction, or any condition that affects drug use and absorption.
- 3: Pre-trial treatment: Use of drugs that significantly affect the P450 metabolic enzyme pathway within 2 weeks before the screening period.
- Current use of cyclosporins or fibrates. Participation in other clinical studies and use of investigational drugs within 28 days prior to the initiation of the study drug.
- The need to use concomitant drugs that may prolong QTc or induce tip torsion ventricular TdP, in addition to antimicrobials used as standard care to prevent or treat infections and other such drugs that investigators...
- 4: Evidence of current uncontrolled cardiovascular disease, including: Uncontrolled high blood pressure. Uncontrolled arrhythmia. Symptomatic congestive heart failure. Unstable angina. Myocardial infarction within the...
- Have a history of uncontrolled seizures, a central nervous system disorder, or a mental illness.
- 5: History of malignant tumors other than OA-EMZL, unless the patient has been cured for more than 3 years.
- 6: Any past or current disease, treatment, or laboratory abnormality that may interfere with the study results or affect the subject's full participation in the study, or the investigator deems the subject unfit to...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.