Actively Recruiting
Ultra-low-dose Radiation Therapy Followed by Orelabrutinib as First-line Treatment for Stage Ⅰ-Ⅱ MALT Lymphoma
Led by Zhejiang Cancer Hospital · Updated on 2026-05-11
60
Participants Needed
2
Research Sites
141 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang Cancer Hospital
Lead Sponsor
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, multicenter Phase 2 clinical trial named the MALT-RO study, evaluating ultra-low-dose radiation therapy followed by orelabrutinib as first-line treatment for adults with Stage I-II MALT lymphoma. The study aims to determine the efficacy and safety profile of this sequential regimen. Eligible participants aged 18 years or older with histologically confirmed MALT lymphoma, measurable lesions, no prior systemic anti-lymphoma therapy, adequate organ function, and an ECOG performance status of 0-1 will receive 4Gy ultra-low-dose radiation (2Gy daily for 2 consecutive days) followed by oral orelabrutinib 150mg once daily for up to 6 cycles (28 days per cycle). Patients with partial response or stable disease after 6 cycles may continue orelabrutinib monotherapy for up to 12 cycles or until disease progression. All participants will undergo regular safety monitoring, tumor assessments, and long-term follow-up every 3 months to evaluate treatment durability. This treatment strategy is designed to improve efficacy and achieve more favorable outcomes compared with standard approaches for MALT lymphoma, while minimizing treatment-related toxicities such as long-term organ damage, xerostomia, cataracts, and other complications related to conventional standard-dose radiation, thereby offering a well-tolerated, convenient, targeted therapeutic option for patients with MALT lymphoma under strict ethical oversight in accordance with the Declaration of Helsinki and Chinese Good Clinical Practice guidelines.
CONDITIONS
Official Title
Ultra-low-dose Radiation Therapy Followed by Orelabrutinib as First-line Treatment for Stage Ⅰ-Ⅱ MALT Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, all genders eligible
- Histologically confirmed MALT lymphoma with at least one measurable lesion larger than 1.0 cm outside the spleen
- No prior systemic anti-tumor therapy after diagnosis, including chemotherapy or targeted therapy
- For primary gastric MALT lymphoma, Helicobacter pylori must be negative or standard eradication therapy must have failed
- ECOG performance status of 0 or 1
- Presence of treatment indications such as symptoms, cytopenias, risk of organ damage, bulky disease, or progression
- Adequate organ function including blood counts, liver and kidney function, and coagulation parameters
- Expected survival of at least 3 months
- Voluntary written informed consent provided before screening
You will not qualify if you...
- Current or past other malignant tumors unless fully treated with complete remission
- Lymphoma involving the central nervous system or transformed to high-grade lymphoma
- Unrecovered non-hematologic toxicities from prior cancer treatments above Grade 1 (except hair loss)
- Significant cardiovascular diseases including advanced heart failure, recent myocardial infarction, arrhythmias needing treatment, low heart function, primary cardiomyopathies, significant QT prolongation, symptomatic coronary artery disease, or uncontrolled hypertension
- Active bleeding or use of anticoagulant drugs within 2 months before screening
- High urine protein levels
- History of deep vein thrombosis or pulmonary embolism within 6 months
- History of organ or stem cell transplantation
- Recent major surgery within 6 weeks or minor surgery within 2 weeks before screening
- HIV/AIDS or other serious infections
- Severe lung diseases including pulmonary fibrosis or pneumonitis
- Previous treatment with BTK inhibitors or related pathway inhibitors
- Drug or alcohol abuse
- Pregnancy, lactation, or unwillingness to use contraception
- Any other condition making participation unsuitable per investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
No. 1, East Banshan Road , Gongshu District
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
2
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
Xiaolin Yuan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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