Marginal zone lymphoma (MZL) is a common type of indolent lymphoma that originates from the marginal zone of lymphoid follicles. This study aims to evaluate targeted therapy based on the prognostic risk stratification of MZL-IPI in newly diagnosed MZL cases requiring systemic treatment, and provides a basis for precision treatment of MZL.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
145
Induction: Obinutuzumab (1000 mg on days 1, 8, and 15 of cycle 1; 1000 mg on day 1 of cycles 2-6, cycle length=21 days) and Orelabrutinib (150 mg once daily).
Induction: Obinutuzumab (1000 mg on days 1, 8, and 15 of cycle 1; 1000 mg on day 1 of cycles 2-6, cycle length=21 days), Orelabrutinib (150 mg once daily), and Lenalidomide (25 mg on days 2-11 of cycles 1-6, cycle length=21 days).
Maintenance: Orelabrutinib monotherapy (150 mg once daily up to 24 months).
2-year progression-free survival
Progression-free survival is defined as the time from registration to the first occurrence of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first; as assessed by the investigator.
Time frame: Baseline up to data cut-off (up to 24 months).
Complete Response Rate after 6 cycles, at 12 months and 24 months
The proportion of patients with complete response after 6 cycles, 12 months and 24 months from treatment start, according to the 2014 Lugano Response Criteria.
Time frame: At the end of cycle 6, at 12 months and 24 months after treatment start.
Overall Response Rate after 6 cycles, at 12 months and 24 months
The proportion of patients with complete and partial response after 6 cycles, 12 months and 24 months from treatment start, according to the 2014 Lugano Response Criteria.
Time frame: At the end of cycle 6, at 12 months and 24 months after treatment start.
Treatment-Related Adverse Events rate as assessed by CTCAE version 5.0
Time frame: From enrollment to study completion (up to approximately 24 months).
Duration of Response (DOR)
Duration of response is defined as the period from the first response (at least PR) to treatment until evidence of disease progression, relapse or death of any cause.
Time frame: From enrollment to study completion (up to approximately 24 months).
Histological transformation rate
Histological transformation rate is defined as the proportion of patients with histological transformation.
Time frame: From enrollment to study completion (up to approximately 24 months).
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Maintenance: Orelabrutinib monotherapy (150 mg once daily up to 24 months).
2-year overall survival
Overall survival is defined as the time from registration to death from any cause.
Time frame: Baseline up to data cut-off (up to 24 months).