Clinical trial · Interventional
Treatment of Orelabrutinib+Hi-CVP Regimen for Previously Untreated MZL
Orelabrutinib Combined With Anti-CD20 Monoclonal Antibody-CVP Regimen for the Treatment of Previously Untreated Marginal Zone Lymphoma:A Pospective, Multicenter, Open-label Phase II Clinical Study
NCT07480863CI-TRIAL-00107179active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Marginal Zone Lymphoma(MZL) | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Orelabrutinib | Drug | — | UNRESOLVED |
| Prednisoneacetatetablets | Drug | — | UNRESOLVED |
| Vincristine | Drug | Vincristine | ALIAS |
| Zuberitamab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with Marginal zone lymphoma who are treatment-naive
- description
- 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.
- interventionNames
- Drug: Orelabrutinib
- Drug: Zuberitamab
- Drug: Cyclophosphamide
- Drug: Vincristine
- Drug: Prednisoneacetatetablets
Primary outcomes (1)
- measure
- 24-month complete remission rate
- timeFrame
- From enrollment to 24 months
- description
- 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.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria:
* 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):
1. Hematology test standards:
1. ANC ≥ 1.0 × 10\^9/L
2. PLT ≥ 75 × 10\^9/L (for patients with confirmed bone marrow involvement: ≥ 50 × 10\^9/L)
3. Hb ≥ 80 g/L
2. Biochemistry test standards:
1. TBIL \< 2 × ULN
2. ALT and AST \< 2.5 × ULN (for patients with liver involvement, ALT and AST \< 5 × ULN)
3. Endogenous creatinine clearance ≥ 40 ml/min (Cockcroft-Gault formula)
* Women of childbearing potential must use reliable contraception or have a negative pregnancy test (blood or urine) within 7 days prior to enrollment and agree to use appropriate contraception during the trial and for 8 weeks after the last dose of the study drug. For men, agreement to use appropriate contraception during the trial and for 8 weeks after the last dose of the study drug or previous surgical sterilization is required
* Subjects voluntarily agree to participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up
Exclusion Criteria:
* 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 resultsReferences
Publications (0)
Data not yet available
No reference posted for this study.