Multi center, randomized, controlled, prospective clinical trial to explore the clinical efficacy and safety of low-dose radiotherapy combined with targeted therapy for localized MALT lymphoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
140
4 Gy in 2 consecutive daily fractions subsequently with orelabrutinib
24 Gy in 12 fractions
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Fudan University Affiliated Minhang Hospital
Shanghai, Shanghai Municipality, China
Huadong Hospital
Shanghai, Shanghai Municipality, China
Complete response rate
The disappearance of all target lesions and the normalization of tumor marker levels, with no new lesions identified.
Time frame: 6 months
Objective Response Rate (ORR)
The proportion of patients who achieve either a complete response (CR) or partial response (PR) as their best overall response, according to predefined response criteria (e.g., Lugano criteria), relative to the total number of evaluable patients.
Time frame: 6 months
Duration of Response (DOR)
The time from the first documented objective response (CR or PR) to the first documented disease progression (PD) or death from any cause, whichever occurs first.
Time frame: 6 months
2-year Event-Free Survival (EFS)
The probability of remaining free from any predefined event (including disease progression, relapse, initiation of new anticancer therapy, or death from any cause) at 2 years from the start of treatment, as estimated by the Kaplan-Meier method.
Time frame: 2 years
2-year Overall Survival (OS)
The probability of remaining alive at 2 years from the start of treatment, regardless of disease status, as estimated by the Kaplan-Meier method.
Time frame: 2 years
2-year Local Control Rate
The probability of the absence of local progression or local recurrence at the irradiated site(s) at 2 years from the start of treatment, as estimated by the Kaplan-Meier method.
Time frame: 2 years
2-year Distant Metastasis Rate
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The proportion of patients who develop new lesions outside the initially involved sites or areas of irradiation within 2 years from the start of treatment. Alternatively, it can be expressed as the cumulative incidence of distant metastasis at 2 years, accounting for competing risks.
Time frame: 2 years
Rate of acute toxicity (any and above grade 3)
toxicities according to CTCAE criteria
Time frame: From enrollment to 3 months after treatment
Rate of late toxicity (any and above grade 3)
toxicities according to CTCAE criteria
Time frame: After 3 months of enrollment