A Single-Arm, Prospective Clinical Study Evaluating the Efficacy and Safety of Sonrotoclax, Zanubrutinib Combined with Obinutuzumab in the First-Line Treatment of Newly Diagnosed Intermediate-to-High-Risk Mantle Cell Lymphoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
The treatment regimen was as follows: In cycle 1 (C1), obinutuzumab 1000 mg was administered intravenously on day 1 (D1); sotoroclax was given at 80 mg on D2, 160 mg on D3, and 320 mg on D4; zanubrutinib was administered at 160 mg twice daily (BID). Each cycle was defined as 28 days. From cycles 2 to 6 (C2-C6), patients received obinutuzumab 1000 mg intravenously on D1, sotoroclax 320 mg once daily, and zanubrutinib 160 mg BID.
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China
Complete response rate
The percentage of participants with a complete response at the end of Cycle 6 was determined on the basis of investigator assessments according to the Lugano Classification for Response Criteria in Lymphoma
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Overall survival
Overall survival (OS) was measured from the date of diagnosis to the date of death or the last follow-up.
Time frame: 2 years after enrollment
Overall response rate
The percentage of participants with overall response was determined on the basis of investigator assessments according to the Lugano Classification for Response Criteria in Lymphoma
Time frame: Overall Response Rate At the end of Cycle 6 (each cycle is 28 days)
Progression free survival
Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, or death from any cause, whichever occurred first.
Time frame: 2 years after enrollment
Treatment-Related Adverse Events
An adverse event is any untoward medical occurrence in a participant receiving a pharmaceutical product that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease that is temporally associated with the use of a pharmaceutical product, whether or not it is considered related to the pharmaceutical product. Preexisting conditions that worsen during a study are also considered adverse events. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: From enrollment to study completion, a maximum of 3 years.
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