A Single-arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of Orelabrutinib Combined With Rituximab as First-line Systemic Treatment for Marginal Zone Lymphoma

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a single-arm, prospective clinical study to evaluate the efficacy and safety of orelabrutinib combined with rituximab as first-line systemic treatment for marginal zone lymphoma.

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

• Age ≥ 18 years, regardless of gender;

• Histologically confirmed CD20-positive marginal zone lymphoma, including MALT, SMZL, and NMZL, with at least one lesion outside the spleen measuring more than 1.5 cm in any axis;

• MZL that has progressed or relapsed after prior local therapy (including surgery, radiotherapy, anti-Helicobacter pylori treatment, and anti-hepatitis C treatment), or is not suitable for local therapy;

• ECOG performance status of 0-2;

• Presence of an indication for treatment as judged by the investigator (symptomatic, cytopenia, risk of end-organ damage, bulky disease, ongoing progression, or patient's desire for treatment);

• Adequate function of major organs, as follows:

• Hematology: Absolute neutrophil count ≥ 1.5×109/L, platelets ≥ 75×109/L, hemoglobin ≥ 75 g/L; if there is bone marrow involvement, absolute neutrophil count ≥ 1.0×109/L, platelets ≥ 50×109/L, hemoglobin ≥ 50 g/L;

• Biochemistry: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), AST or ALT ≤ 2 times ULN; serum creatinine ≤ 1.5 times ULN; serum amylase ≤ ULN;

• Coagulation: International normalized ratio (INR) ≤ 1.5 times ULN.

• Life expectancy of ≥ 3 months;

• Voluntary written informed consent obtained before screening for the trial.

Locations
Other Locations
China
Dongyang People's Hospital
RECRUITING
Dongyang
Affiliated Hangzhou First People's Hospital
RECRUITING
Hangzhou
Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Zhejiang cancer Hospital
RECRUITING
Hangzhou
Huzhou Central Hospital
RECRUITING
Huzhou
Affiliated Hospital of Jiaxing University
RECRUITING
Jiaxing
The Second Affiliated Hospital of Jiaxing University
RECRUITING
Jiaxing
Lishui central Hospital
RECRUITING
Lishui
the Affiliated Peopele'S Hospital of Ningbo University
RECRUITING
Ningbo
Quzhou People's Hospital
RECRUITING
Quzhou
Shaoxing Central Hospital
RECRUITING
Shaoxing
shaoxing People's Hospital
RECRUITING
Shaoxing
Taizhou Central Hospital
RECRUITING
Taizhou
Taizhou First People's Hospital
RECRUITING
Taizhou
Taizhou Hospital ofzhejiang Province
RECRUITING
Taizhou
The Second Affiliated Hospital and Yuying childrens Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Yuyao People's Hospital
RECRUITING
Yuyao
Affiliated Zhuji Hospital ofWenzhou Medical University
RECRUITING
Zhuji
Contact Information
Primary
yun Liang
liangyun@zju.edu.cn
13957136178
Time Frame
Start Date: 2025-03-11
Estimated Completion Date: 2029-09-11
Participants
Target number of participants: 51
Treatments
Experimental: orelabrutinib combined with rituximab regimen
All participants will receive induction therapy with the orelabrutinib and rituximab regimen. The treatment cycle is 28 days, with a total of 6 cycles. The induction treatment period is as follows:~Cycle 1: Rituximab, 375 mg/m², on Day 1. Cycles 2-6:Orelabrutinib, 150 mg, once daily orally, from Day 1 to Day 28. Rituximab, 375 mg/m², on Day 1.~Patients who achieve a partial response (PR) or better will enter a 2-year maintenance period with orelabrutinib.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: Huzhou Central Hospital, Dongyang People's Hospital, Ningbo People's Hospital, Shaoxing People's Hospital, Taizhou First People's Hospital, Shaoxing Central Hospital, Yuyao People's Hospital, Zhuji People's hospital, Taizhou Central Hospital affiliated to Taizhou University, Second Affiliated Hospital of Wenzhou Medical University, The People's Hospital of Quzhou, Zhejiang University, Zhejiang Cancer Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Second Affiliated Hospital of Jiaxing University, Affiliated Hospital of Jiaxing University, The Central Hospital of Lishui City

This content was sourced from clinicaltrials.gov

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