Orelabrutinib Followed by Response-adapted Ultra-low Dose 4Gy Radiation as First-line Treatment of MALT Lymphoma

February 24, 2026 updated by: Yizhen Liu, Fudan University

A Prospective, Multicenter, Phase II Study of Orelabrutinib Followed by Response-adapted Ultra-low Dose 4Gy Radiation as First-line Treatment of Local-stage Mucosa Associated Lymphoid Tissue Extranodal Marginal Zone Lymphoma

Investigate the efficacy and safety of Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation in the treatment of local-stage MALT lymphoma

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective, multicenter trial is trying to evaluate the efficacy and safety of Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation as first-line treatment of local-stage mucosa associated lymphoid tissue extranodal marginal zone lymphoma

Study Type

Interventional

Enrollment (Actual)

50

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 Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center

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:

  • Age ≥ 18 years old
  • Histologically confirmed mucosa-associated lymphoid tissue (MALT) lymphoma
  • Lugano stage I-II
  • ECOG 0-2
  • Signed informed consent
  • Having sufficient organ function: a) Hematopoietic function: Neutrophils ≥ 1.0 × 109/L, PLT ≥ 50 × 109/L, Hb ≥ 80g/L; b) Liver function: bilirubin ≤1.5 times the upper limit of normal (ULN), ALT and AST<3 x ULN, serum albumin ≥ 30 g/L; c) Renal function: serum Cr<1.5 × ULN, creatinine clearance rate ≥ 50mL/min (calculated according to the standard Cockcroft Gault formula, if renal dysfunction is caused by tumor compression, creatinine clearance rate ≥ 30mL/min); d) Coagulation function (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant therapy at the time of screening): International standardized ratio (INR) ≤ 1.5 x ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.

Exclusion Criteria:

  • Recent major surgery (within 4 weeks prior to enrollment), except for diagnostic surgery
  • Have uncontrolled intercurrent diseases (cardiovascular and cerebrovascular diseases, coagulation disorders, severe infectious diseases) including but not limited to: severe acute or chronic infection requiring systemic treatment, symptomatic congestive heart failure (NYHA III-IV) or symptomatic or poorly controlled arrhythmias, arterial hypertension (systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥100mmHg) that is not controlled even with standard treatment, unstable angina, active peptic ulcer or bleeding disorder;
  • Severe concomitant diseases that interfere with treatment
  • Active interstitial pneumonia
  • Active chronic hepatitis B infection (defined as HBV DNA positive; patients with latent or prior hepatitis B infection (defined as positive for hepatitis B surface antigen or hepatitis B core total antibody) can be included if HBV-DNA is undetectable at screening. The above-mentioned patients must voluntarily undergo regular DNA tests and receive appropriate antiviral therapy as prescribed)
  • Positive hepatitis C test result (for patients who are positive for HCV antibodies, only polymerase chain reaction (PCR) shows a negative HCV RNA can participate)
  • Patients with active HIV and syphilis infections;
  • Pregnant or lactating women
  • Patients with multiple factors affecting oral medication (such as dysphagia, nausea, vomiting, chronic diarrhea, and intestinal obstruction)
  • The researcher determined that patients are not suitable to participate in this study.

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: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiation
Orelabrutinib was administrated for 12 weeks, followed by response-adapted ultra-low dose 4Gy radiation for local stage MALT EMZL
Drug: Orelabrutinib
Orelabrutinib was administrated for 12 weeks
Radiation: response-adapted radiation
response-adapted ultra-low dose 4Gy radiation
Other Names:
  • radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year event-free survival (EFS)
Time Frame: 1 year
the period from the date of patients sign informed consent to the observed event for any reason
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year progression-free survival (PFS)
Time Frame: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
From date of patients sign 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-year event-free survival (EFS)
Time Frame: From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years
the period from the date of patients sign informed consent to the observed event for any reason
From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years
6-months CR rate
Time Frame: up to 6 months
the ratio of numbers of patients with complete response to all the participants receiving treatment
up to 6 months
2-year overall survival rate
Time Frame: From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years
time between the date of patients sign informed consent and the date of death or the date of last follow-up time
From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: Throughout the treatment period, up to 1 year
Record the name of adverse events and number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Throughout the treatment period, up to 1 year
Quality of life questionnaire(EORTC QLQ-C30)
Time Frame: Up to 1 year
evaluate patients' quality of life by questionnaire using EORTC QLQ-C30.There are a total of 30 entries. Among them, items 29 and 30 are divided into seven levels, ranging from 1 to 7 points based on their answer options; The other items are divided into four levels: none, a little, many to many, and are rated directly on a scale of 1 to 4.
Up to 1 year

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Principal Investigator: Rong Tao, Fudan University

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 (Actual)

September 10, 2024

Primary Completion (Actual)

August 18, 2025

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

August 31, 2024

First Submitted That Met QC Criteria

August 31, 2024

First Posted (Actual)

September 4, 2024

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iNHL-04

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.

Clinical Trials on Lymphoma, B-Cell, Marginal Zone

Clinical Trials on Orelabrutinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe