This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with obinutuzumab and lenalidomide in untreated marginal zone lymphoma. The primary objective was the best complete response rate (CRR).
Marginal zone lymphomas (MZL) are a type of lymphoma that originates from the marginal zone tissue of the lymphoid follicles (Mucosa-associated lymphoid tissue, MALT), and include three subtypes: MALT lymphoma, nodal MZL, and splenic MZL. The incidence of MZL is second only to diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL), accounting for approximately 7.8% of all non-Hodgkin lymphomas (NHL). MZL is considered an indolent lymphoma, with patients generally having a better overall survival prognosis. Despite this, some patients still face the challenges of disease relapse or transformation into large cell lymphoma, leading to a poor prognosis. We conduct this prospective, phase II, single-arm clinical study to initially explore the efficacy and safety of Orelabrutinib combined with obinutuzumab and lenalidomide in patients with previously untreated marginal zone lymphoma. The patients will be treated with 6 cycles of OGL regimen. Patients with CR/PR after 6 cycles of OGL treatment will be treated with 6 cycles of single-agent orelabrutinib regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Orelabrutinib: 150mg qd d1-d21/C1-C6 obinutuzumab: 1000mg iv d1,d8,d15/c1, 1000mg iv d1/C2-C6 lenalidomide：25mg po qd d1-14/C1-C6 Orelabrutinib: 150mg qd d1-d28/C7-C12
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGthe best complete response rate
CRR is defined as the proportion of patients with a best response of CR
Time frame: At the end of cycle 12(the first 6 cycles are 21 days each, and the following 6 cycles are 28 days each)
ORR
ORR is defined as the proportion of patients with a response of CR or PR
Time frame: At the end of therapy(up to 42 weeks)
CRR
CRR is defined as the proportion of patients with a best response of CR
Time frame: At the end of therapy(up to 42 weeks)
The best ORR
The best ORR is defined as the proportion of patients with a best response of CR or PR
Time frame: At the end of cycle 12(the first 6 cycles are 21 days each, and the following 6 cycles are 28 days each)
2 years progression-free survival Progression free survival (PFS)
PFS is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment.
Time frame: From date of signing the 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 years overall survival
Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date.
Time frame: From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years]
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TTR
TTR is defined as the time from registration to the first response.
Time frame: Up to 2 years
Duration of Response (DOR)
Duration of response as defined as the period from the first response (at least PR) to treatment until evidence of disease progression, relapse or death of any cause. Patients alive without progression and relapse will be censored at the latest tumor assessment date or the stopping date.
Time frame: Up to 2 years
The occurrence of adverse events and serious adverse events
Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.
Time frame: One month after the end of treatment（up to 46 weeks）