NCT07441993

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
30mo left

Started Jan 2026

Typical duration for phase_2

Geographic Reach
1 country

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Jan 2026Dec 2028

Study Start

First participant enrolled

January 5, 2026

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

February 3, 2026

Last Update Submit

February 26, 2026

Conditions

Marginal Zone Lymphoma

Keywords

LymphomaMarginal zone lymphomaOrelabrutinib

Outcome Measures

Primary Outcomes (1)

  • Overall response rate (ORR)

    The ORR is defined as the proportion of patients with a response of CR or PR.

    From the initiation of treatment to the end of induction therapy of cycle 6 (each cycle is 28 days)

Secondary Outcomes (6)

  • Complete response rate (CRR)

    From the initiation of treatment to the end of induction therapy of cycle 6 (each cycle is 28 days)

  • Time to response (TTR)

    1years

  • Duration of Response (DOR)

    From the first demonstration of response until disease progression/death, up to 1 years

  • Progression-free survival (PFS)

    From the date of enrollment until the date of first documented progression, up to 2 years

  • Overall survival (OS)

    From the date of the initiation of treatment until the date of death, up to 2 years

  • +1 more secondary outcomes

Study Arms (1)

Marginal zone lymphoma: orelabrutinib

EXPERIMENTAL
Drug: Orelabrutinib

Interventions

OrelabrutinibDRUG

Induction phase (cycle 1-6): Orelabrutinib (150 mg)

Marginal zone lymphoma: orelabrutinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Lymphoma involving the central nervous system or transformation to high-grade;
  • Uncontrolled or significant cardiovascular diseases, including:
  • New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first dose of the study drug, or arrhythmia requiring treatment at screening, with left ventricular ejection fraction (LVEF) \<50%;
  • Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, or unclassified cardiomyopathy);
  • History of clinically significant QTc interval prolongation, or QTc interval \>470 ms for females or \>450 ms for males at screening;
  • Subjects with symptomatic coronary artery disease requiring medication;
  • Poorly controlled hypertension (failure to achieve target blood pressure after at least one month of lifestyle modification and treatment with three or more antihypertensive drugs, including diuretics, at maximally tolerated doses, or requiring four or more antihypertensive drugs for effective control).
  • Active bleeding within 2 months prior to screening, or current use of anticoagulants, or investigator-determined clear bleeding tendency;
  • History of deep vein thrombosis or pulmonary embolism within the past six months;
  • Urine protein ≥2+ and 24-hour urine protein quantification ≥2 g/24 hours;
  • Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or subjects with total gastrectomy;
  • Current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or other conditions affecting lung function;
  • Pregnant or breastfeeding women, or subjects of childbearing potential unwilling to use contraception;
  • Continuous use of drugs with moderate to strong cytochrome P450 CYP3A inhibition or strong induction effects;
  • Other conditions deemed by the investigator as unsuitable for participation in this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Xiangyang Central Hospital

Xiangyang, Hubei, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Jiangsu Province People's Hospital

Nanjing, Jiangsu, China

RECRUITING

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

Shandong Cancer Hospital & Institute

Jinan, Shandong, China

RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

RECRUITING

Beijing Tongren Hospital, Capital Medical University

Beijing, China

RECRUITING

Hematology Hospital, Chinese Academy of Medical Sciences

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal ZoneLymphoma

Interventions

orelabrutinib

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Shuhua yi

    Hematology Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Liang Wang

    Beijing Tongren Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuhua Yi

CONTACT

022-23909035yishuhua@ihcams.ac.cn

Liang Wang

CONTACT

15001108693wangliangtrhos@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2026

First Posted

March 2, 2026

Study Start

January 5, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(14)