Actively Recruiting
The Treatment of Ocular Adnexal Extranodal Marginal Zone B-cell Lymphoma by Orelabrutinib and Radiotherapy
Led by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Updated on 2024-07-22
50
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Treatment of Ocular Adnexal Extranodal Marginal Zone B-cell Lymphoma by Orelabrutinib and Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 18-75 years
- Newly diagnosed with marginal zone B-cell lymphoma of the ocular adnexa confirmed by surgical biopsy
- Early Ann Arbor stage I or II with lesions larger than 1 cm visible on imaging
- Laboratory tests showing white blood cell count 3.0x10^9/L, absolute neutrophil count 1.5x10^9/L, hemoglobin 90 g/L, platelets 75x10^9/L
- Liver function with transaminase levels 3 times and bilirubin 1.5 times the upper normal limit
- Serum creatinine clearance 30 mL/min and myocardial enzymes less than 2 times the upper normal limit
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
- Provide informed consent voluntarily
You will not qualify if you...
- Pregnant or lactating women, or women of childbearing potential refusing contraception
- Inability to swallow, chronic diarrhea, intestinal obstruction, or conditions affecting drug absorption
- Use of drugs affecting the P450 enzyme pathway within 2 weeks before screening
- Current use of cyclosporins or fibrates
- Participation in other clinical studies or investigational drug use within 28 days before study
- Use of drugs that prolong QTc interval or induce torsade de pointes, except essential antimicrobials
- Uncontrolled cardiovascular disease including high blood pressure, arrhythmia, heart failure, unstable angina, or recent myocardial infarction
- Severe infections requiring systemic treatment
- Known HIV infection or active hepatitis B or C infection
- History of uncontrolled seizures, central nervous system disorders, or mental illness
- History of other malignant tumors unless cured for more than 3 years
- Any disease, treatment, or abnormality interfering with study participation or results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
J
Jun Shi
CONTACT
S
Shaoxin Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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