Orelabrutinib Plus Low-Dose Radiotherapy Or Rituximab For Ocular Adnexal MALT Lymphoma (NCT07247383) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Orelabrutinib Plus Low-Dose Radiotherapy Or Rituximab For Ocular Adnexal MALT Lymphoma
China39 participantsStarted 2025-09-19
Plain-language summary
This is a phase II, prospective clinical study to evaluate the efficacy and safety of Orelabrutinib combined with Low-Dose Radiotherapy or Rituximab in the treatment of Ocular Adnexal MALT Lymphoma
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Aged ≥18 years, with no gender restriction;
* 2\. Patients with OAML confirmed by histopathology;
* 3\. Ann Arbor stage (I\~II);
* 4\. ECOG performance status score of 0-2;
* 5\. No previous systemic treatment;
* 6\. Major organ functions meet the following criteria:
* (1). Blood routine: Absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥75×10⁹/L, hemoglobin ≥75g/L; In case of bone marrow involvement, absolute neutrophil count ≥1.0×10⁹/L, platelet count ≥50×10⁹/L, hemoglobin ≥50g/L;
* (2). Blood biochemistry: Total bilirubin ≤1.5×ULN, AST or ALT ≤2×ULN; Serum creatinine ≤1.5×ULN; Serum amylase ≤ULN;
* (3). Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN.
* 7\. Expected survival time ≥3 months
* 8\. Voluntarily sign a written informed consent form before trial screening.
Exclusion Criteria:
* 1\. Current or previous history of other malignant tumors, except those with evidence of no recurrence or metastasis for at least 5 years after radical treatment;
* 2\. Lymphoma involving the central nervous system or transformed to high-grade lymphoma;
* 3\. Non-hematological toxicities from previous anti-tumor treatment have not recovered to ≤ Grade 1 (except alopecia);
* 4\. Uncontrolled or significant cardiovascular diseases, including:
* (1). Congestive heart failure of New York Heart Association (NYHA) Class II or higher, unstable angina pectoris, myocardial infarction within 6 months before the first administration of the study d…
What they're measuring
1
Complete Response Rate (CR)
Timeframe: up to 6 months
Trial details
NCT IDNCT07247383
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University