NCT07022223

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
41mo left

Started Mar 2025

Typical duration for phase_2

Geographic Reach
1 country

18 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 Progress26%
Mar 2025Sep 2029

Study Start

First participant enrolled

March 11, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2029

Last Updated

June 15, 2025

Status Verified

March 1, 2025

Enrollment Period

2.5 years

First QC Date

June 1, 2025

Last Update Submit

June 8, 2025

Conditions

Marginal Zone Lymphoma(MZL)

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate (ORR)

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

    up to 6 months

Secondary Outcomes (7)

  • Complete Response Rate (CR)

    up to 6 months

  • Best Overall Response (BOR)

    up to 6 months

  • Duration of Response (DoR)

    Up to 2 years

  • 2 years progression-free survival Progression free survival

    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

    From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years

  • +2 more secondary outcomes

Study Arms (1)

orelabrutinib combined with rituximab regimen

EXPERIMENTAL

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.

Drug: orelabrutinib combined with rituximab regimen

Interventions

orelabrutinib combined with rituximab regimenDRUG

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.

orelabrutinib combined with rituximab regimen

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Currently or previously having other malignancies, unless there is evidence of no recurrence or metastasis within the past 5 years after curative treatment;
  • Lymphoma involvement of the central nervous system or transformation to high-grade lymphoma;
  • Non-hematological toxicities from prior anti-cancer treatments not recovered to ≤ Grade 1 (excluding alopecia);
  • Presence of uncontrolled or significant cardiovascular disease, including:
  • New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months before the first administration of the study drug, or arrhythmias requiring treatment at screening, left ventricular ejection fraction (LVEF) \< 50%;
  • Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy);
  • History of clinically significant QTc interval prolongation, or QTc interval \> 470 ms for females, \> 450 ms for males during the screening period;
  • Symptomatic or medically treated coronary artery disease;
  • Uncontrolled hypertension (defined as blood pressure not reaching target levels despite a reasonable and tolerable full dose of three or more antihypertensive drugs (including diuretics) for more than one month, or requiring four or more antihypertensive drugs to effectively control blood pressure).
  • Active bleeding within 2 months before screening, or currently taking anticoagulant drugs, or deemed by the investigator to have a clear tendency to bleed;
  • Urine protein ≥ 2+, and 24-hour urine protein quantification ≥ 2 g/24 hours;
  • History of deep vein thrombosis or pulmonary embolism within the past six months;
  • History of organ transplantation or allogeneic bone marrow transplantation;
  • Active infection or uncontrolled HBV (HBsAg positive and/or HBcAb positive with positive HBV DNA titer), HCV Ab positive, HIV/AIDS, or other severe infectious diseases;
  • Currently having pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or other conditions that significantly affect pulmonary function;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Dongyang People's Hospital

Dongyang, China

RECRUITING

Affiliated Hangzhou First People's Hospital

Hangzhou, China

RECRUITING

Zhejiang cancer Hospital

Hangzhou, China

RECRUITING

Huzhou Central Hospital

Huzhou, China

RECRUITING

Affiliated Hospital of Jiaxing University

Jiaxing, China

RECRUITING

The Second Affiliated Hospital of Jiaxing University

Jiaxing, China

RECRUITING

Lishui central Hospital

Lishui, China

RECRUITING

the Affiliated Peopele'S Hospital of Ningbo University

Ningbo, China

RECRUITING

Quzhou People's Hospital

Quzhou, China

RECRUITING

Shaoxing Central Hospital

Shaoxing, China

RECRUITING

shaoxing People's Hospital

Shaoxing, China

RECRUITING

Taizhou Central Hospital

Taizhou, China

RECRUITING

Taizhou First People's Hospital

Taizhou, China

RECRUITING

Taizhou Hospital ofzhejiang Province

Taizhou, China

RECRUITING

The Second Affiliated Hospital and Yuying childrens Hospital of Wenzhou Medical University

Wenzhou, China

RECRUITING

Yuyao People's Hospital

Yuyao, China

RECRUITING

Affiliated Zhuji Hospital ofWenzhou Medical University

Zhuji, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Condition Hierarchy (Ancestors)

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

Central Study Contacts

yun Liang

CONTACT

13957136178liangyun@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Orelabrutinib combined with rituximab regimen
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2025

First Posted

June 15, 2025

Study Start

March 11, 2025

Primary Completion (Estimated)

September 11, 2027

Study Completion (Estimated)

September 11, 2029

Last Updated

June 15, 2025

Record last verified: 2025-03

Locations

CN(18)