A Prospective Study of Response-adapted Low-dose Radiotherapy Combined With Orelabrutinib for Localized Mucosa-associated Lymphoid Tissue Extranodal Marginal Zone Lymphoma

July 10, 2026 updated by: WANG SHUBEI, Ruijin Hospital
Multi center, randomized, controlled, prospective clinical trial to explore the clinical efficacy and safety of low-dose radiotherapy combined with targeted therapy for localized MALT lymphoma.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
      • Shanghai, Shanghai Municipality, China
        • Fudan University Affiliated Minhang Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients must meet all of the following criteria to be eligible for enrollment in this study:
  • The patient voluntarily agrees to participate in this study and provides written informed consent;
  • Age ≥ 18 years;
  • Histopathologically confirmed diagnosis of extranodal marginal zone B-cell lymphoma of the mucosa-associated lymphoid tissue (MALT) type;
  • Involved sites include but are not limited to: orbit, parotid gland, thyroid, Helicobacter pylori (H. pylori)-negative gastric MALT (in this study, H. pylori-negative gastric MALT is defined as negative results on both gastric mucosal tissue biopsy and serum H. pylori antibody test within the past 6 months; for patients with unknown prior H. pylori status who have received anti-H. pylori therapy, a positive serum H. pylori antibody test is permissible, provided that a subsequent gastroscopy or urea breath test confirms negativity);
  • Lugano stage I-II disease;
  • Able to swallow tablets normally;
  • Eastern Cooperative Oncology Group performance status (ECOG-PS) score of 0-2;
  • No prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy for MALT lymphoma;
  • Life expectancy ≥ 12 months;

  • Adequate major organ function, meeting the following criteria:

    1. Hematological parameters: absolute neutrophil count ≥ 1.0 × 10⁹/L; platelet count ≥ 50 × 10⁹/L; hemoglobin ≥ 80 g/L;
    2. Biochemical parameters: total bilirubin < 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN; serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance > 50 mL/min;
  • Female patients of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment and must agree to use highly effective methods of contraception during the study period and for 120 days after the last dose. Male patients with female partners of childbearing potential must be surgically sterile or agree to use highly effective methods of contraception during the study period and for 120 days after the last dose.

Exclusion Criteria:

  • Patients who meet any of the following criteria will be excluded from enrollment in this study:
  • Major surgery (excluding diagnostic surgery) within 4 weeks prior to enrollment;
  • Previous or concurrent diagnosis of another malignancy, with the exception of adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast;
  • Active chronic hepatitis B infection, defined as detectable HBV DNA;
  • Active HIV or syphilis infection;
  • Presence of severe concomitant medical conditions or circumstances that may affect the patient's eligibility or safety during the study period;
  • Pregnant or breastfeeding women;
  • Presence of active psychiatric disorders or other psychological conditions that may impair the patient's ability to provide informed consent or understand the study procedures;
  • Patients considered by the investigator to have poor compliance; Pathologically or radiologically confirmed distant metastasis; Other factors that, in the investigator's judgment, may affect the study results or necessitate premature termination of the study, including but not limited to alcohol abuse, drug abuse, other severe diseases (including psychiatric disorders) requiring concomitant treatment, significant laboratory abnormalities, or family/social circumstances that may compromise patient safety.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: research arm
Patients will receive a total dose of 4 Gy, delivered as 2 consecutive daily fractions, encompassing all initially involved disease sites. Following radiotherapy, patients will then receive oral orelabrutinib at a dose of 150 mg once daily, administered in 4-week cycles for a total of 6 cycles.
Radiation: Radiation (Very low dose)
4 Gy in 2 consecutive daily fractions subsequently with orelabrutinib
Other Names:
  • targeted therapy
Active Comparator: control arm
Patients will receive a total of 24 Gy in 12 fractions comprehensively to all initially involved sites of disease over 12 consecutive business days.
Radiation: Radiation (Standard)
24 Gy in 12 fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate
Time Frame: 6 months
The disappearance of all target lesions and the normalization of tumor marker levels, with no new lesions identified.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of acute toxicity (any and above grade 3)
Time Frame: From enrollment to 3 months after treatment
toxicities according to CTCAE criteria
From enrollment to 3 months after treatment
Rate of late toxicity (any and above grade 3)
Time Frame: After 3 months of enrollment
toxicities according to CTCAE criteria
After 3 months of enrollment
Objective Response Rate (ORR)
Time Frame: 6 months
The proportion of patients who achieve either a complete response (CR) or partial response (PR) as their best overall response, according to predefined response criteria (e.g., Lugano criteria), relative to the total number of evaluable patients.
6 months
Duration of Response (DOR)
Time Frame: 6 months
The time from the first documented objective response (CR or PR) to the first documented disease progression (PD) or death from any cause, whichever occurs first.
6 months
2-year Event-Free Survival (EFS)
Time Frame: 2 years
The probability of remaining free from any predefined event (including disease progression, relapse, initiation of new anticancer therapy, or death from any cause) at 2 years from the start of treatment, as estimated by the Kaplan-Meier method.
2 years
2-year Overall Survival (OS)
Time Frame: 2 years
The probability of remaining alive at 2 years from the start of treatment, regardless of disease status, as estimated by the Kaplan-Meier method.
2 years
2-year Local Control Rate
Time Frame: 2 years
The probability of the absence of local progression or local recurrence at the irradiated site(s) at 2 years from the start of treatment, as estimated by the Kaplan-Meier method.
2 years
2-year Distant Metastasis Rate
Time Frame: 2 years
The proportion of patients who develop new lesions outside the initially involved sites or areas of irradiation within 2 years from the start of treatment. Alternatively, it can be expressed as the cumulative incidence of distant metastasis at 2 years, accounting for competing risks.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Principal Investigator: Shu-Bei Wang, MD, Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

May 1, 2031

Study Registration Dates

First Submitted

July 6, 2026

First Submitted That Met QC Criteria

July 10, 2026

First Posted (Actual)

July 15, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026255

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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