Marginal Zone Lymphoma(MZL)
Conditions
Keywords
Orelabrutinib combined with Rituximab versus R-CVP
Brief summary
This study is a randomized, open-label, multicenter, prospective clinical trial aimed at evaluating the efficacy and safety of orelabrutinib combined with rituximab for the previously untreat MZL
Detailed description
For patients with advanced-stage MZL who require treatment, immunochemotherapy is the standard therapy, including regimens such as BR, R-CHOP, R-CVP, etc. The second-generation BTK inhibitor, orelabrutinib, has shown promising efficacy in relapsed/refractory MZL, suggesting that a chemofree regimen combining orelabrutinib with rituximab could also achieve good clinical outcomes in first-line treatment of MZL. However, there is still a lack of prospective studies to confirm this. This study plans to compare the efficacy and safety of orelabrutinib combined with rituximab followed by maintenance therapy with orelabrutinib to the R-CVP regimen.
Interventions
DRUGOrelabrutinib
150mg po
DRUGrituximab
375mg/m\^2, intravenous
DRUGCyclophosphamide
750mg/m\^2
DRUGVincristine
1.4mg/m\^2
60mg/m\^2
Sponsors
Fei Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Age ≥18 years； 2.ECOG performance status level 0\ 2； 3.Life expectancy of at least 12 weeks; 4.Confirmed CD20-positive marginal zone lymphoma according to the WHO 2008 lymphoma classification criteria, including splenic MZL, nodal MZL, and extranodal MZL subtypes; 5.Measurable lesions detected by enhanced computed tomography (CT) or magnetic resonance imaging (MRI); 6.Indication for treatment according to NCCN guidelines and no prior systemic treatment for MZL; 7.Normal function of major organs; 8.Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and must be willing to use appropriate contraceptive methods during the trial period and for 8 weeks after the last administration of the trial medication. For men, they must agree to use appropriate contraceptive methods during the trial period and for 8 weeks after the last administration of the trial medication or have undergone surgical sterilization; 9.The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with follow-up. \-
Exclusion criteria
1. Patients with central nervous system involvement; 2. History or concurrent other untreated malignant tumors, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and superficial bladder cancer; 3. Patients with the following cardiovascular diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval for males ≥450 ms, for females ≥470 ms); Class III to IV heart failure according to NYHA standards, or echocardiography indicating left ventricular ejection fraction (LVEF) \<50%; 4. Coagulation abnormalities (INR \>1.5 or prothrombin time (PT) \>ULN+4 seconds or APTT \>1.5 ULN), with a tendency to bleed or undergoing thrombolytic or anticoagulant therapy; 5. Arterial/venous thrombotic events within 12 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 6. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.); 7. Major surgical procedures or severe traumatic injuries, fractures, or ulcers within 4 weeks prior to enrollment; 8. Factors that significantly affect the absorption of oral medications, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 9. Active infections requiring antimicrobial treatment (e.g., requiring antibacterial, antiviral drugs, excluding chronic hepatitis B antiviral treatment, antifungal treatment); 10. Active hepatitis B (HBV DNA ≥2000 IU/mL or 104 copies/mL) or hepatitis C (hepatitis C antibody positive, and HCV RNA above the lower limit of detection of the analytical method); 11. History of substance abuse and inability to quit or mental disorders; 12. Participation in other anticancer drug clinical trials within 4 weeks prior to enrollment; 13. Received treatment with potent CYP3A4 inhibitors within 7 days prior to enrollment, or received treatment with potent CYP3A4 inducers within 12 days prior to study participation; 14. Pregnant or breastfeeding women; patients of childbearing potential who are unwilling or unable to use effective contraceptive measures; 15. Other situations judged by the investigator that may affect the conduct of the clinical study and the determination of study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRR | up to two years | The proportion of patients who achieve Complete Remission (CR) at the end of the combined antitumor treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to two years | ORR is defined as the percentage of participants with partial or complete response |
| PFS rate at 24month | Two years after the last patient was enrolled. | the proportion of patients who have not experienced disease progression or death due to any cause within 2 years of receiving the first dose of the study medication. |
| Safety parameters | up to 3 years | Type, frequency, and severity of AEs |
Countries
China
Contacts
Primary ContactYulan Zhou Doctor, PhD
Outcome results
None listed