Marginal Zone Lymphoma (MZL) Clinical Trials

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Orelabrutinib for the Treatment of Marginal Zone Lymphoma: A Phase II, Multicenter, Open-label Study

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years, regardless of gender;

• Patients with histopathologically confirmed stage I/II marginal zone lymphoma;

• ECOG performance status score of 0-2;

• Major organ functions meeting the following criteria:

‣ Blood tests: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow involvement, ANC ≥1.0×10\^9/L, platelets ≥50×10\^9/L, hemoglobin ≥50g/L;

⁃ Blood biochemistry: Total bilirubin ≤1.5×ULN, AST or ALT ≤2×ULN; serum creatinine ≤1.5×ULN;

• Coagulation function: International normalized ratio (INR) ≤1.5×ULN;

• Expected survival time ≥12 months;

• Voluntary written informed consent signed before trial screening.

Locations
Other Locations
China
Beijing Tongren Hospital, Capital Medical University
RECRUITING
Beijing
The First Bethune Hospital of Jilin University
RECRUITING
Changchun
The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
Qilu Hospital of Shandong University
RECRUITING
Jinan
Shandong Cancer Hospital & Institute
RECRUITING
Jinan
Shandong Provincial Hospital
RECRUITING
Jinan
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Jiangsu Province People's Hospital
RECRUITING
Nanjing
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Hematology Hospital, Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Xiangyang Central Hospital
RECRUITING
Xiangyang
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Shuhua Yi
yishuhua@ihcams.ac.cn
022-23909035
Backup
Liang Wang
wangliangtrhos@126.com
15001108693
Time Frame
Start Date: 2026-01-05
Estimated Completion Date: 2028-12
Participants
Target number of participants: 30
Treatments
Experimental: Marginal zone lymphoma: orelabrutinib
Related Therapeutic Areas
Sponsors
Collaborators: Beijing Tongren Hospital
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov

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