Oxygen Study-Orelabrutinib Combined With Obinutuzumab(O2) for First-Line Treatment of Marginal Zone Lymphoma
- Conditions
- Marginal Zone Lymphoma
- Registration Number
- NCT06566807
- Lead Sponsor
- Huai'an First People's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Aged =18 years, gender not limited;<br><br> - Histopathologically confirmed CD20-positive marginal zone lymphoma including MALT,<br> SMZL, NMZL;<br><br> - MZL that has progressed, recurred, or is not suitable for local treatment after<br> previous local treatment (local treatments include surgery, radiotherapy,<br> Helicobacter pylori treatment, and hepatitis C treatment);<br><br> - ECOG 0-2;<br><br> - Indication for treatment as judged by the investigator (symptomatic, with cytopenia,<br> at risk of end-organ damage, bulky disease, persistent progression, or patient's<br> desire for treatment);<br><br> - Major organ function meets the following criteria: a) Complete blood count: Absolute<br> neutrophil count =1.5×10^9/L, platelets =75×10^9/L, hemoglobin =75g/L; if<br> accompanied by bone marrow invasion, absolute neutrophil count =1.0×10^9/L,<br> platelets =50×10^9/L, hemoglobin =50g/L; b) Blood biochemistry: Total bilirubin =1.5<br> ULN, AST or ALT =2 ULN; serum creatinine =1.5 ULN; serum amylase =ULN; c)<br> Coagulation function: International normalized ratio (INR) =1.5 ULN.<br><br> - Expected survival time =3 months;<br><br> - Voluntarily sign a written informed consent form before the trial screening.<br><br>Exclusion Criteria:<br><br> - Currently or previously diagnosed with other malignant tumors, unless curative<br> treatment has been performed and there is evidence of no recurrence or metastasis<br> within the last 5 years;<br><br> - Lymphoma involving the central nervous system or transformation to a higher grade;<br><br> - Active bleeding within 2 months prior to screening, or currently taking<br> anticoagulant medications, or the investigator considers there to be a definite<br> bleeding tendency;<br><br> - Major surgery within 6 weeks prior to screening or minor surgery within 2 weeks<br> prior to screening;<br><br> - Active infection or uncontrolled HBV (positive for HBsAg and/or HBcAb and positive<br> for HBV DNA titer), HCV Ab positive, HIV/AIDS, or other serious infectious diseases;<br><br> - Any mental or cognitive disorder that may limit the understanding, execution, and<br> compliance with the informed consent form and the study;<br><br> - Pregnant or lactating women and women of childbearing age who are unwilling to take<br> contraceptive measures;<br><br> - Need to continuously take drugs with moderate to severe inhibitory or strong<br> inductive effects on cytochrome P450 CYP3A;<br><br> - Other conditions that the investigator considers unsuitable for participating in<br> this trial.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate (ORR)
- Secondary Outcome Measures
Name Time Method the complete response rate;BOR;Duration of Response (DOR);TTR;24-month time to CR TTCR24;CR at 24 months (CR24);2 years progression-free survival;2 years overall survival;The occurrence of adverse events