Investigate the efficacy and safety of Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation in the treatment of local-stage MALT lymphoma
This prospective, multicenter trial is trying to evaluate the efficacy and safety of Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation as first-line treatment of local-stage mucosa associated lymphoid tissue extranodal marginal zone lymphoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Orelabrutinib was administrated for 12 weeks
response-adapted ultra-low dose 4Gy radiation
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITING1-year event-free survival (EFS)
the period from the date of patients sign informed consent to the observed event for any reason
Time frame: 1 year
6-months CR rate
the ratio of numbers of patients with complete response to all the participants receiving treatment
Time frame: up to 6 months
2-year event-free survival (EFS)
the period from the date of patients sign informed consent to the observed event for any reason
Time frame: From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years
2-year progression-free survival (PFS)
the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
Time frame: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
2-year overall survival rate
time between the date of patients sign informed consent and the date of death or the date of last follow-up time
Time frame: From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Record the name of adverse events and number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Throughout the treatment period, up to 1 year
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Quality of life questionnaire(EORTC QLQ-C30)
evaluate patients' quality of life by questionnaire using EORTC QLQ-C30.There are a total of 30 entries. Among them, items 29 and 30 are divided into seven levels, ranging from 1 to 7 points based on their answer options; The other items are divided into four levels: none, a little, many to many, and are rated directly on a scale of 1 to 4.
Time frame: Up to 1 year