Orelabrutinib Plus Low-Dose Radiotherapy Or Rituximab For Ocular Adnexal MALT Lymphoma

NCT07247383 | Active Not Recruiting Phase 2

• 1 other identifier: 2025-0995
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Marginal Zone Lymphoma of Ocular Adnexal; Marginal Zone Lymphoma(MZL)

Keywords

Marginal zone lymphoma; Orelabrutinib; Phase II Trail: Orelabrutinib Plus Low-Dose Radiotherapy Or Rituximab For Ocular Adnexal MALT Lymphoma（Efficacy & Safety）

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate (CR)

  The rate of patients who achieved complete response after treatment

  up to 6 months

Secondary Outcomes (4)

• Overall Response Rate (ORR)

  up to 6 months

• Progression free survival (PFS)

  Up to 2 years

• Overall Survival

  Up to 2 years

• Adverse Event (AE)

  After signing the ICF until 28 Days (± 7 days) after the last dose

Study Arms (3)

AnnArbor 1

EXPERIMENTAL

Radiotherapy 2GY \* 2 + Orelabrutinib 150 mg qd; 28 days per cycle for 4 cycles

Drug: Orelabrutinib (ICP-022); Radiation: radiotherapy

AnnArbor 2

EXPERIMENTAL

Rituximab plus Orelabrutinib 150 mg QD, 28 days per cycle for 4 cycles

Drug: Orelabrutinib (ICP-022); Drug: Rituximab (R)

AnnArbor 3-4

EXPERIMENTAL

Rituximab plus Orelabrutinib 150 mg QD, 28 days per cycle for 6 cycles

Drug: Orelabrutinib (ICP-022); Drug: Rituximab (R)

Interventions

Orelabrutinib (ICP-022) DRUG

Orelabrutinib was administered in 4 or 6 cycles, respectively, based on subjects' AnnArbor stage as assessed by PETCT，150mg QD D1-28

AnnArbor 1; AnnArbor 2; AnnArbor 3-4

radiotherapy RADIATION

Radiotherapy 2Gy\*2

AnnArbor 1

Rituximab (R) DRUG

Rituximab 375mg/m2 D1

AnnArbor 2; AnnArbor 3-4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Aged ≥18 years, with no gender restriction;
• \. Patients with OAML confirmed by histopathology;
• \. Ann Arbor stage (I\~II);
• \. ECOG performance status score of 0-2;
• \. No previous systemic treatment;
• \. 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.
• \. Expected survival time ≥3 months
• \. Voluntarily sign a written informed consent form before trial screening.

You may not qualify if:

• \. 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;
• \. Lymphoma involving the central nervous system or transformed to high-grade lymphoma;
• \. Non-hematological toxicities from previous anti-tumor treatment have not recovered to ≤ Grade 1 (except alopecia);
• \. 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 drug, or arrhythmia requiring treatment at screening, or left ventricular ejection fraction (LVEF) \< 50%;
• (2). Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy);
• (3). History of clinically significant QTc interval prolongation, or QTc interval at screening (female \> 470ms, male \> 450ms);
• (4). Subjects with symptomatic coronary heart disease requiring medication;
• (5). Subjects with poorly controlled hypertension (blood pressure not reaching the target after more than 1 month of using 3 or more reasonable and tolerable maximum-dose antihypertensive drugs (including diuretics) on the basis of lifestyle modification, or blood pressure can only be effectively controlled by taking 4 or more antihypertensive drugs);
• \. Active bleeding within 2 months before screening, or current use of anticoagulant drugs, or clear bleeding tendency as judged by the investigator;
• \. Urine protein ≥ 2+, and 24-hour urine protein quantification ≥ 2g/24h;
• \. History of deep vein thrombosis or pulmonary embolism within 6 months before screening;
• \. History of organ transplantation or allogeneic bone marrow transplantation;
• \. Active infection, or uncontrolled HBV (HBsAg positive and/or HBcAb positive with positive HBV DNA titer), HCV Ab positive, HIV/AIDS, or other severe infectious diseases;
• \. Subjects with severe pulmonary function impairment such as current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, etc.;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2ndAffiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

orelabrutinib; Radiotherapy; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 25, 2025
• Study Start: September 19, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)