Status:
RECRUITING
Orelabrutinib Combined With Zuberitamab in the Initial Treatment of MZL
Lead Sponsor:
Li Zhiming
Conditions:
Initial MZL
Untreated MZL
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a multi-center, prospective cohort study. The main purpose of study is to evaluate the efficacy and safety of Orelabrutinib combined with Zuberitamab in the initial treatment of MZL Main effic...
Detailed Description
Marginal Zone Lymphoma (MZL) is a group of B-cell malignancies believed to originate from B lymphocytes, typically found in the marginal zones of lymphoid follicles in the spleen, lymph nodes, and muc...
Eligibility Criteria
Inclusion
- 1\. Age 18 years or older; 2. ECOG performance status (PS) level 0\~2; 3. The expected survival is not less than 12 weeks; 4. CD20-positive marginal area lymphoma confirmed according to WHO2008 lymphoma classification standard, including splenic MZL, lymph node MZL and extranodal MZL subtypes; 5. MZL with stage III/IV disease and stage I/II disease recurrence or progression after local treatment can also be included, and patients who have received BTKi inhibitor therapy for more than 6 months can also be included; 6. Enhanced computerized tomography/magnetic resonance imaging (CT/MRI) to detect measurable lesions; 7. Indications for MZL treatment that meet NCCN guidelines and have not received systematic treatment for MZL in the past (anti-infective treatment such as anti-HP and HCV is not systemic treatment); 8. The main organ function is normal and meet the following criteria :
- blood routine examination standards must meet:
- ANC\>1.0×109/L;
- PLT\>75×109/L (≥50×109/L for patients with confirmed bone marrow infiltration);
- Hb\>80g/dL;
- Biochemical examination should meet the following criteria :
- TBIL\<2×ULN;
- ALT and AST\<2.5XULN(for patients with liver invasion,ALT and AST\<5×ULN);
- Endogenous creatinine clearance ≥40ml/min (Cockcroft-Gault formula). 9. Women of childbearing age must have been using reliable contraception or had a pregnancy test (serum or urine) within 7 days of enrol with a negative result and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last dose of the test drug. For men, consent to use appropriate methods of contraception or surgical sterilization during the trial period and 8 weeks after the last dose of the trial drug; 10. The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.
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Exclusion
- Patients with central nervous system invasion;
- Previous or co-existing uncured malignancies, except cured skin basal cell MZL clinical trial protocol cancer, cervical carcinoma in situ and superficial bladder cancer;
- Patients with the following cardiovascular diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval 2450 ms for men and 2470 ms for women); According to NYHA standards, patients with grade III to V cardiac insufficiency or left ventricular ejection fraction (LVEF) \<50% indicated by cardiac color ultrasound;
- Abnormal coagulation function (INR\>1.5 or prothrombin time (PT) \>ULN+4 seconds or APTT \>1.5 ULN), have a tendency to hemorrhage or are receiving thrombolytic or anticoagulant therapy;
- Arteriovenous thrombosis events occurring in the 12 months prior to enrollment, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
- The presence of known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophiliac, coagulation disorder, thrombocytopenia, hypersplenism, etc.);
- Had major surgery or severe traumatic injury, fracture or ulcer within 4 weeks of enrollment;
- Have significant factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction;
- Active infections that require antimicrobial treatment (such as antimicrobial drugs, antiviral drugs, excluding chronic hepatitis B anti-hepatitis B treatment, antifungal drug treatment);
- Active hepatitis B (HBV DNA\>2000IU/mL or 104 copy numbers /mL) or hepatitis C (hepatitis C antibody positive with HCVRNA higher than the lower detection limit of analytical methods);
- Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
- Had participated in other anti-tumor drug clinical trials within 4 weeks before enrollment;
- Patients who had received potent CYP3A4 inhibitors within 7 days before enrollment, or had received potent CYP3A4 inducers within 12MZL clinical trial regimen days before enrollment;
- Pregnant or lactating women; A fertile patient who is unwilling or unable to take effective contraceptive measures;
- The investigator determines other circumstances that may affect the conduct of the clinical study and the determination of the study results.
Key Trial Info
Start Date :
November 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06985472
Start Date
November 13 2024
End Date
December 31 2027
Last Update
May 22 2025
Active Locations (2)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 515800