This is a single-arm, multicenter, prospective, phase II study. The primary objective is to assess the efficacy and safety of orelabrutinib in treatment-naïve patients with marginal zone lymphoma.
Marginal zone lymphoma (MZL) is a group of indolent B-cell malignancies originating from B lymphocytes, primarily occurring in the marginal zones of the spleen, lymph nodes, and mucosa-associated lymphoid tissues. Its histological features are characterized by abnormal proliferation of marginal zone cells surrounding lymphoid follicles. The Bruton tyrosine kinase (BTK) signaling pathway plays a critical role in B-cell receptor-mediated signal transduction and is significant in the development and progression of various B-cell malignancies. Ibrutinib, as the first BTK inhibitor, has demonstrated remarkable efficacy in the treatment of B-cell lymphomas. However, its poor kinase selectivity leads to a high incidence of off-target toxicities, including thrombocytopenia, neutropenia, bleeding, fatigue, rash, and atrial fibrillation in clinical settings, which limits its long-term use. Orelabrutinib is a highly selective oral small-molecule BTK inhibitor belonging to the nicotinamide class of compounds. It covalently binds to BTK and represents a new generation of selective irreversible BTK inhibitors. Due to its higher selectivity for BTK and favorable safety profile observed in previous human studies, orelabrutinib holds promise as a superior therapeutic option for B-cell malignancies. To further improve clinical outcomes for MZL patients, there is an urgent need to explore treatment strategies with better efficacy and lower toxicity. This study aims to evaluate the efficacy and safety of orelabrutinib in previously untreated localized-stage MZL patients, providing new therapeutic evidence for this population. This study is a multicenter, prospective trial involving previously untreated patients with MZL. During the induction phase (cycles 1-6), patients will receive orelabrutinib 150 mg, administered in 28-day treatment cycles. Following completion of the induction phase, patients will be followed during a post-treatment follow-up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Induction phase (cycle 1-6): Orelabrutinib (150 mg)
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
Overall response rate (ORR)
The ORR is defined as the proportion of patients with a response of CR or PR.
Time frame: From the initiation of treatment to the end of induction therapy of cycle 6 (each cycle is 28 days)
Complete response rate (CRR)
Complete response rate is defined as the proportion of patients with a response of CR.
Time frame: From the initiation of treatment to the end of induction therapy of cycle 6 (each cycle is 28 days)
Time to response (TTR)
TTR is defined as the time from the start of therapy to the first response.
Time frame: 1years
Duration of Response (DOR)
DOR is defined as the time from documentation of response to treatment to the first documentation of tumor progression or death due to any cause, whichever comes first.
Time frame: From the first demonstration of response until disease progression/death, up to 1 years
Progression-free survival (PFS)
PFS is defined as the time from enrollment to disease progression or death from any cause. For patients who remain alive and progression-free at the data cutoff date, PFS will be censored at the last tumor assessment date.
Time frame: From the date of enrollment until the date of first documented progression, up to 2 years
Overall survival (OS)
OS is defined as the time from the initiation of treatment to death from any cause. Patients alive at the data cutoff date will have their OS censored at the date of the last follow-up.
Time frame: From the date of the initiation of treatment until the date of death, up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGXiangyang Central Hospital
Xiangyang, Hubei, China
RECRUITINGThe Second Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGJiangsu Province People's Hospital
Nanjing, Jiangsu, China
RECRUITINGAffiliated Hospital of Nantong University
Nantong, Jiangsu, China
RECRUITINGThe First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGThe First Bethune Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGQilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITING...and 4 more locations
Adverse events (AEs)
AEs will be graded according to the NCI-CTCAE Version 5.0.
Time frame: From the date of enrollment until the date of death, up to 1 years