This is a prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with obinutuzumab a in untreated marginal zone lymphoma. It is planned to recruit 45 patients. The primary endpoint is the complete remission rate at 12 months.
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. For patients with marginal zone lymphoma who have indications for systemic anti-tumor treatment, therapeutic options include rituximab monotherapy or more intensive immunochemotherapy regimens in combination with bendamustine, chlorambucil, CHOP regimen (cyclophosphamide, vincristine, doxorubicin, prednisone), etc. This is a prospective, phase II, single-arm clinical study to initially explore the efficacy and safety of Orelabrutinib combined with obinutuzumab in patients with previously untreated marginal zone lymphoma. The patients will be treated with 6 cycles of OG regimen. Patients with CR/PR after 6 cycles of OG treatment will be treated with 18 cycles of single-agent orelabrutinib regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Orelabrutinib and obinutuzumab 6cycles ;orelabrutinib 150mg
China Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, China
RECRUITINGthe complete response rate
CRR is defined as the proportion of patients with a response of CR
Time frame: At 12 months.
CRR
CRR is defined as the proportion of patients with a best response of CR
Time frame: At the end of induction therapy(6cycles). 28days/cycle
ORR
The ORR is defined as the proportion of patients with a response of CR
Time frame: At 12 months.
BOR
The BOR is defined as the proportion of patients with a best response of CR or PR
Time frame: At 12 months.
2 years progression-free survival
Progression free survival (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]
TTR
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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.
Time frame: One month after discontinuation of treatment