Status:
RECRUITING
The Treatment of Ocular Adnexal Extranodal Marginal Zone B-cell Lymphoma by Orelabrutinib and Radiotherapy
Lead Sponsor:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions:
Extranodal Marginal Zone B-cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 opt...
Eligibility Criteria
Inclusion
- 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 subjects must provide informed consent and voluntarily sign the written informed consent form themselves or through their legal representatives before participating in the study.
Exclusion
- 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 consider essential for treatment.
- 4: Evidence of current uncontrolled cardiovascular disease, including: Uncontrolled high blood pressure. Uncontrolled arrhythmia. Symptomatic congestive heart failure. Unstable angina. Myocardial infarction within the past 6 months. Severe acute or chronic infections requiring systemic treatment. Known human immunodeficiency virus (HIV) infection , or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- 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 participate in the study.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06503276
Start Date
November 1 2023
End Date
October 31 2028
Last Update
July 22 2024
Active Locations (1)
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1
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200011