Treatment for ocular adnexal lymphoma using Orelabrutinib and radiotherapy
The Efficacy of Combination of Orelabrutinib and Ultra-low Dose Radiotherapy in the First-line Treatment of Early Ocular Adnexal Extranodal Marginal Zone B-cell Lymphoma
This study is testing if a new drug called Orelabrutinib combined with low-dose radiation can help newly diagnosed patients with early-stage ocular adnexal lymphoma feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Academic / other |
| Drugs / interventions | rituximab, Orelabrutinib, radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06503276 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Orelabrutinib combined with ultra-low dose radiotherapy for treating patients with ocular adnexal extranodal marginal zone B-cell lymphoma. The study focuses on newly diagnosed patients in early stages (I/II) of the disease, aiming to improve treatment outcomes and overall survival rates. Participants will receive a specific dosage of radiotherapy while being monitored for their response to the treatment. The trial seeks to establish a more effective treatment protocol for this rare type of lymphoma.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18-75 with newly diagnosed ocular adnexal marginal zone B-cell lymphoma at stage I/II.
Not a fit: Patients who are pregnant, lactating, or have severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the prognosis and quality of life for patients with ocular adnexal lymphoma.
How similar studies have performed: While there have been studies on radiotherapy for similar conditions, the combination of Orelabrutinib with ultra-low dose radiotherapy is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 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 Criteria: * 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jun Shi — Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Study coordinator: Jun Shi
- Email: junshi@sjtu.edu.cn
- Phone: 13701867597
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.