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Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)Phase 2NCT07705308

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

A Phase 2 study testing Radiation (Very low dose) and Radiation (Standard) in people with Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT), run by Ruijin Hospital at 3 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Radiation (Very low dose) and Radiation (Standard)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
3 sitesChina
Study dates
1 Aug 2026to 1 May 2031
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

  • 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;
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  • 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:
  • Hematological parameters: absolute neutrophil count ≥ 1.0 × 10⁹/L; platelet count ≥ 50 × 10⁹/L; hemoglobin ≥ 80 g/L;
  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

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

Shu-Bei Wang, MD contact

+86-021-64370045 ext. 602400

wangshubei@163.com

Gang Cai, MD contact

+86-021-64370045 ext. 602400

cg11855@rjh.com.cn

China3 sites

  • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

    Jiang-Bo Wan, MD, +86-021-25077999, jiangbowan@sina.com

  • Fudan University Affiliated Minhang Hospital

    Shanghai, Shanghai Municipality

    Yun-Hua Hou, MD, +86-021-64923400, hou_yunhua@fudan.edu.cn

  • Huadong Hospital

    Shanghai, Shanghai Municipality

    Jie-Xian Ma, MD, +86-021-62483180, jiexianma@hotmail.com

Other trials in China

About this study

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.

Being tested
Radiation (Very low dose), Radiation (Standard)
Keywords
radiotherapy, MALT lymphoma, targeted therapy
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.

  • Radiation (Very low dose)Radiation

    Also called targeted therapy

    4 Gy in 2 consecutive daily fractions subsequently with orelabrutinib

  • Radiation (Standard)Radiation

    24 Gy in 12 fractions

Study groups in NCT07705308
Study groupRoleWhat they receive
research armExperimentalPatients 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.
Receives: Radiation: Radiation (Very low dose)
control armActive comparatorPatients will receive a total of 24 Gy in 12 fractions comprehensively to all initially involved sites of disease over 12 consecutive business days.
Receives: Radiation: Radiation (Standard)

What is being measured

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

  1. Complete response rate

    The disappearance of all target lesions and the normalization of tumor marker levels, with no new lesions identified.

    Measured: 6 months

Secondary outcomes (8)

  1. Objective Response Rate (ORR)

    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.

    Measured: 6 months

  2. Duration of Response (DOR)

    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.

    Measured: 6 months

  3. 2-year Event-Free Survival (EFS)

    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.

    Measured: 2 years

  4. 2-year Overall Survival (OS)

    The probability of remaining alive at 2 years from the start of treatment, regardless of disease status, as estimated by the Kaplan-Meier method.

    Measured: 2 years

  5. 2-year Local Control Rate

    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.

    Measured: 2 years

  6. 2-year Distant Metastasis Rate

    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.

    Measured: 2 years

  7. Rate of acute toxicity (any and above grade 3)

    toxicities according to CTCAE criteria

    Measured: From enrollment to 3 months after treatment

  8. Rate of late toxicity (any and above grade 3)

    toxicities according to CTCAE criteria

    Measured: After 3 months of enrollment

Timeline

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

  1. First posted15 Jul 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 May 2031 (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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07705308
Sponsor's protocol ID
2026255
Status last verified
Jul 2026
First submitted
6 Jul 2026
Last updated
15 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Deng LJ, Zhou KS, Liu LH, Zhang MZ, Li ZM, Ji CY, Xu W, Liu T, Xu B, Wang X, Gao SJ, Zhang HL, Hu Y, Li Y, Cheng Y, Yang HY, Cao JN, Zhu ZM, Hu JD, Zhang W, Jing HM, Ding KY, Zhang XY, Zhao RB, Zhang B, Tian YM, Song YP, Song YQ, Zhu J. Orelabrutinib for the treatment of relapsed or refractory MCL: a phase 1/2, open-label, multicenter, single-arm study. Blood Adv. 2023 Aug 22;7(16):4349-4357. doi: 10.1182/bloodadvances.2022009168.

    PubMed 37078706

  • Pinnix CC, Dabaja BS, Gunther JR, Fang PQ, Wu SY, Nastoupil LJ, Strati P, Nair R, Ahmed S, Steiner R, Westin J, Neelapu S, Rodriguez MA, Lee HJ, Wang M, Flowers C, Feng L, Esmaeli B. Response-Adapted Ultralow-Dose Radiation Therapy for Orbital Indolent B-Cell Lymphoma: A Phase 2 Nonrandomized Controlled Trial. JAMA Oncol. 2024 Sep 1;10(9):1195-1203. doi: 10.1001/jamaoncol.2024.2112.

    PubMed 38990564

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiation (Very low dose) and Radiation (Standard) in people with Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT), run by Ruijin Hospital at 3 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 14 inclusion and 9 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: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 Shu-Bei Wang, MD (+86-021-64370045 ext. 602400, wangshubei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate (time frame: 6 months). 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 NCT07705308, which also lists 2 linked publications.

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 15 Jul 2026.

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