RecruitingPhase 2NCT06503276

The Treatment of Ocular Adnexal Extranodal Marginal Zone B-cell Lymphoma by 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


Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Enrollment

50 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

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 optimal treatment strategy for OA-EMZL. Studies have shown that patients who wait for postoperative observation have a 5-year PFS of approximately 80% and a 10-year PFS of 63%. Therefore, radiotherapy remains an important treatment for stage I/II OA-EMZL patients, but the dosage of radiotherapy remains controversial. In 2014, Hoskin PJ et al. found that the complete response rate and effective rate of patients in the standard 24Gy radiation dose group were 71% and 91%, while those in the 4Gy radiation dose group were 55% and 87%, respectively. Meanwhile, the PFS of patients with 4Gy radiation dose was lower than that of the group with 24Gy radiation dose, but there was no significant difference in OS between the two groups. However, in a study conducted by Chelius M et al. in 2021, they found that the incidence of both early and late toxic effects was significantly higher in the\>4Gy radiation dose group than in the\<4Gy radiation dose group. These toxic effects inevitably affect the quality of life of patients. Therefore, investigators plan to adopt a combination of ultra-low dose radiotherapy and drug therapy, which not only reduces the side effects of radiotherapy, but also improves the complete response rate of treatment and reduces disease progression or recurrence. However, studies have shown that radiotherapy combined with rituximab cannot improve the disease-specific survival rate of OA-EMZL. Therefore, BTK inhibitors (BTKi), as a novel targeted drug for the treatment of EMZL, have been used to treat relapsed and refractory EZML by interfering with BCR signals. Based on the above research, investigators plan to explore the efficacy of combination therapy with Orelabrutinib and ultra-low dose radiotherapy (4Gy) in the treatment of stage I/II OA-EMZL.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of a targeted oral drug (orelabrutinib, a BTK inhibitor) and radiation therapy for newly diagnosed marginal zone B-cell lymphoma of the eye area (ocular adnexa), aiming for a less aggressive but effective treatment approach. **You may be eligible if...** - You are between 18 and 75 years old - You have been newly diagnosed with marginal zone B-cell lymphoma of the eye area (confirmed by biopsy) - Your lymphoma is at an early stage (stage I or II) with measurable tumors on imaging - Your blood counts, liver, and kidney function meet minimum requirements - Your ECOG performance score is 0–2 **You may NOT be eligible if...** - You are pregnant or breastfeeding, or refuse contraception - You have difficulty swallowing, chronic diarrhea, or bowel obstruction - You have taken drugs that strongly affect liver enzymes (CYP450) in the past 2 weeks, or are on certain heart medications - You have uncontrolled heart disease (high blood pressure, arrhythmia, recent heart attack) - You have HIV, active hepatitis B or C - You have a history of seizures or serious mental illness - You have had another cancer in the past 3 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOrelabrutinib

Orelabrutinib PO will be administered as per the schedule specified in the respective arm

RADIATIONUltra-low dose radiotherapy

2 Gy radiotherapy will be administerd twice in the first cycle


Locations(1)

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

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NCT06503276