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Lymphoma, B-Cell, Marginal ZonePhase 2NCT06583837

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

A Phase 2 study testing Orelabrutinib and response-adapted radiation in people with Lymphoma, B-Cell, Marginal Zone, run by Fudan University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, B-Cell, Marginal Zone
What is being tested?
Orelabrutinib and response-adapted radiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
10 Sep 2024to Sep 2027
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 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.

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: 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

Read the 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

Being tested
Orelabrutinib, response-adapted radiation
Medical subject headings
Lymphoma, B-Cell, Marginal Zone

What participants receive

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

  • OrelabrutinibDrug

    Orelabrutinib was administrated for 12 weeks

  • response-adapted radiationRadiation

    Also called radiation

    response-adapted ultra-low dose 4Gy radiation

Study groups in NCT06583837
Study groupRoleWhat they receive
Orelabrutinib followed by response-adapted ultra-low dose 4Gy radiationExperimentalOrelabrutinib was administrated for 12 weeks, followed by response-adapted ultra-low dose 4Gy radiation for local stage MALT EMZL
Receives: Drug: Orelabrutinib; Radiation: response-adapted radiation

What is being measured

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

  1. 1-year event-free survival (EFS)

    the period from the date of patients sign informed consent to the observed event for any reason

    Measured: 1 year

Secondary outcomes (6)

  1. 6-months CR rate

    the ratio of numbers of patients with complete response to all the participants receiving treatment

    Measured: up to 6 months

  2. 2-year event-free survival (EFS)

    the period from the date of patients sign informed consent to the observed event for any reason

    Measured: 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

  3. 2-year progression-free survival (PFS)

    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

    Measured: 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

  4. 2-year overall survival rate

    time between the date of patients sign informed consent and the date of death or the date of last follow-up time

    Measured: 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

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Record the name of adverse events and number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: Throughout the treatment period, up to 1 year

  6. Quality of life questionnaire(EORTC QLQ-C30)

    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.

    Measured: Up to 1 year

Timeline

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

  1. First posted4 Sep 2024
  2. Study start10 Sep 2024
  3. Primary completion18 Aug 2025
  4. Study completionSep 2027 (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
Sequential
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06583837
Sponsor's protocol ID
iNHL-04
Status last verified
Feb 2026
First submitted
31 Aug 2024
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Orelabrutinib and response-adapted radiation in people with Lymphoma, B-Cell, Marginal Zone, run by Fudan University at 1 site 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 6 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year event-free survival (EFS) (time frame: 1 year). 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 NCT06583837.

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 27 Feb 2026.

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