Ultra-low-dose Radiation Therapy Followed by Orelabrutinib as First-line Treatment for Stage Ⅰ-Ⅱ … (NCT07554898) | Clinical Trial Compass
RecruitingPhase 2
Ultra-low-dose Radiation Therapy Followed by Orelabrutinib as First-line Treatment for Stage Ⅰ-Ⅱ MALT Lymphoma: A Prospective, Multicenter Phase Ⅱ Study
China60 participantsStarted 2026-04-16
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years, all genders eligible;
✓. Histopathologically confirmed MALT lymphoma (extranodal marginal zone lymphoma) with at least one measurable lesion outside the spleen, with any diameter \> 1.0 cm;
✓. No prior systemic anti-tumor therapy after diagnosis (including chemotherapy, targeted therapy, rituximab, etc.).
✓. ECOG performance status score of 0-1;
✓. Presence of treatment indications as judged by the investigator (including symptoms, cytopenias, risk of end-organ damage, bulky disease, or persistent progression);
✓. Adequate major organ function, meeting the following criteria:
. Current or history of other malignant tumors, except for those who have achieved complete remission after radical treatment;
✕. Lymphoma involvement of the central nervous system or transformation to high-grade lymphoma;
✕. Patients with other tumors who have not recovered from non-hematologic toxicities of prior anti-tumor therapy to ≤ Grade 1 (except for alopecia);
✕. Uncontrolled or significant cardiovascular diseases, including:
✕. Congestive heart failure of New York Heart Association (NYHA) Class II or above, unstable angina, myocardial infarction within 6 months before the first dose of the study drug, or arrhythmias requiring treatment at screening, or left ventricular ejection fraction (LVEF) \< 50%;
✕. Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, or unclassified cardiomyopathy);
✕. History of clinically significant QTc interval prolongation, or QTc interval at screening \> 470 ms for females or \> 450 ms for males;
✕. Subjects with symptomatic coronary artery disease requiring medication;