Treatment of Orelabrutinib+Hi-CVP Regimen for Previously Untreated MZL

NCT07480863 | Active Not Recruiting Phase 2

• 1 other identifier: NCCH0037
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with previously untreated Marginal zone lymphoma (MZL), a treatment regimen of Orelabrutinib,Zuberitamab combined with Cyclophosphamide,Vincristine,Prednisoneacetatetablets is planned to be used.

Conditions

Marginal Zone Lymphoma(MZL)

Outcome Measures

Primary Outcomes (1)

• 24-month complete remission rate

  All visible tumor lesions have completely disappeared, no new lesions have appeared, and this has been maintained for at least 4 weeks at 24-month.

  From enrollment to 24 months

Secondary Outcomes (4)

• Objective response rate (ORR) at the end of induction therapy

  From enrollment to the end of induction treatment at 8 weeks

• Complete remission rate (CRR) at the end of induction therapy

  From enrollment to the end of induction treatment at 8 weeks

• 24-month progression-free survival rate

  From enrollment to 24 months

• 24-Month Overall Survival Rate

  From enrollment to 24 months

Study Arms (1)

Patients with Marginal zone lymphoma who are treatment-naive

EXPERIMENTAL

After the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred.

Drug: Orelabrutinib; Drug: Zuberitamab; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisoneacetatetablets

Interventions

Orelabrutinib DRUG

After the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred.

Also known as: Orelabrutinib Tablets

Patients with Marginal zone lymphoma who are treatment-naive

Prednisoneacetatetablets DRUG

After the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred.

Also known as: Decadron

Patients with Marginal zone lymphoma who are treatment-naive

Zuberitamab DRUG

After the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred.

Also known as: Zebutumab

Patients with Marginal zone lymphoma who are treatment-naive

Cyclophosphamide DRUG

After the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred.

Also known as: Cytoxan, Endoxan

Patients with Marginal zone lymphoma who are treatment-naive

Vincristine DRUG

After the patient received one cycle of the anti-CD20 monoclonal antibody CVP regimen, obinutuzumab was added starting from the second cycle for combination therapy. After a total of five cycles of the obinutuzumab combined with the anti-CD20 monoclonal antibody CVP regimen, maintenance treatment with obinutuzumab monotherapy was administered for 18 cycles or until disease progression or unacceptable toxicity occurred.

Also known as: VDS

Patients with Marginal zone lymphoma who are treatment-naive

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• ECOG performance status (PS) 0-2
• Expected survival of at least 12 weeks
• CD20-positive marginal zone lymphoma confirmed according to WHO 2022 lymphoma classification standards, including the three subtypes: nodal MZL, extranodal MZL, and splenic MZL
• Measurable lesions by contrast-enhanced computed tomography/magnetic resonance imaging (CT/MRI)
• Meet the NCCN guideline criteria for MZL treatment and have not previously received systemic therapy for MZL (excluding hormone therapy and anti-infective treatment)
• Main organ function within normal limits, meeting the following criteria (excluding abnormalities caused by lymphoma):
• Hematology test standards:
• ANC ≥ 1.0 × 10\^9/L
• PLT ≥ 75 × 10\^9/L (for patients with confirmed bone marrow involvement: ≥ 50 × 10\^9/L)
• Hb ≥ 80 g/L
• Biochemistry test standards:
• TBIL \< 2 × ULN
• ALT and AST \< 2.5 × ULN (for patients with liver involvement, ALT and AST \< 5 × ULN)
• Endogenous creatinine clearance ≥ 40 ml/min (Cockcroft-Gault formula)

You may not qualify if:

• Patients with central nervous system involvement
• Patients with a history of or concurrent untreated malignant tumors, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and superficial bladder cancer
• Patients with the following cardiovascular diseases: myocardial ischemia or myocardial infarction of grade II or above, uncontrolled arrhythmias (including QTc interval ≥450 ms for men, ≥470 ms for women); heart failure of NYHA class III-IV, or left ventricular ejection fraction (LVEF) \<50% as indicated by cardiac ultrasonography; 4. Coagulation dysfunction (INR \>1.5 or prothrombin time (PT) \> ULN + 4 seconds, or APTT \>1.5 ULN), bleeding tendency, or currently receiving thrombolytic or anticoagulant therapy
• Arterial or venous thrombotic events occurring within 12 months prior to enrollment, such as cerebrovascular events (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, or pulmonary embolism
• Known genetic or acquired bleeding or thrombotic disorders (e.g., hemophilia, coagulation disorders)
• Major surgery or severe traumatic injury, fracture, or ulceration within 4 weeks prior to enrollment
• Factors significantly affecting oral drug absorption, such as dysphagia, chronic diarrhea, or intestinal obstruction
• Active infections requiring antimicrobial treatment (e.g., antibacterial or antiviral drugs, excluding chronic hepatitis B antiviral therapy or antifungal treatments); 10. Active hepatitis B (HBV DNA ≥2000 IU/mL or 104 copies/mL) or hepatitis C (HCV antibody positive and HCV RNA above the detection limit of the assay)
• History of substance abuse of psychiatric drugs that cannot be discontinued or mental disorders
• Participation in another anti-tumor drug clinical trial within 4 weeks prior to enrollment
• Treatment with strong CYP3A4 inhibitors within 7 days prior to enrollment, or treatment with strong CYP3A4 inducers within 12 days prior to enrollment
• Pregnant or breastfeeding women; patients of childbearing potential who are unwilling or unable to use effective contraception
• Other conditions that the investigator deems may affect the conduction of the clinical study or the assessment of study results

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• InnoCare Pharma Inc.: collaborator
• BioRay Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, beijing,

Beijing, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

orelabrutinib; Cyclophosphamide; Vincristine; Calcium Dobesilate

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)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Xinxin Cao, doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicenter, prospective, interventional study, with a planned number of subjects: approximately 65 cases.

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 2, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)