AzTrials
AzTrials

Marginal Zone LymphomaPhase 2MZL-IIT-ONCT07441993

Exploratory Study of Orelabrutinib in the Treatment of Early-stage Untreated MZL

A Phase 2 study testing Orelabrutinib in people with Marginal Zone Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 14 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Marginal Zone Lymphoma
What is being tested?
Orelabrutinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
14 sitesChina
Study dates
5 Jan 2026to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 9Show fewer
  • Coagulation function: International normalized ratio (INR) ≤1.5×ULN;
  • Expected survival time ≥12 months;
  • Voluntary written informed consent signed before trial screening.

Who cannot join

  • 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;
Show all 15Show fewer
  • 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.

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shuhua Yi contact

022-23909035

yishuhua@ihcams.ac.cn

Liang Wang contact

15001108693

wangliangtrhos@126.com

14 sites in 1 country

China14 sites, 14 recruiting

  • Beijing Tongren Hospital, Capital Medical University

    Beijing

    Recruiting

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

    Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong

    Recruiting

  • Shandong Cancer Hospital & Institute

    Jinan, Shandong

    Recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Recruiting

  • Jiangsu Province People's Hospital

    Nanjing, Jiangsu

    Recruiting

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu

    Recruiting

  • Hematology Hospital, Chinese Academy of Medical Sciences

    Tianjin

    Recruiting

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

    Wuhan, Hubei

    Recruiting

  • Xiangyang Central Hospital

    Xiangyang, Hubei

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Recruiting

Other trials in China

About this study

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

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.

Read the detailed description

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.

Being tested
Orelabrutinib
Keywords
Lymphoma, Marginal zone lymphoma, Orelabrutinib
Medical subject headings
Lymphoma, B-Cell, Marginal Zone, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrelabrutinibDrug

    Induction phase (cycle 1-6):

    Orelabrutinib (150 mg)

Study groups in NCT07441993
Study groupRoleWhat they receive
Marginal zone lymphoma: orelabrutinibExperimentalNot described
Receives: Drug: Orelabrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

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

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

Secondary outcomes (6)

  1. Complete response rate (CRR)

    Complete response rate is defined as the proportion of patients with a response of CR.

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

  2. Time to response (TTR)

    TTR is defined as the time from the start of therapy to the first response.

    Measured: 1years

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. Adverse events (AEs)

    AEs will be graded according to the NCI-CTCAE Version 5.0.

    Measured: From the date of enrollment until the date of death, up to 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2026
  2. Study start5 Jan 2026
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07441993
Sponsor's protocol ID
IIT2025145（CUREMZL02）
Acronym
MZL-IIT-O
Status last verified
Feb 2026
First submitted
3 Feb 2026
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Orelabrutinib in people with Marginal Zone Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shuhua Yi (022-23909035, yishuhua@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: From the initiation of treatment to the end of induction therapy of cycle 6 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07441993.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in