A Phase III Clinical Trial of High-dose Rituximab (500mg/m²) Combined With CHOP Regimen in the Treatment of Male Patient With Newly Diagnosed Advanced DLBCL
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Registration Number
- NCT06573645
- Lead Sponsor
- Xia Yi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Male
- Target Recruitment
- 428
Key Inclusion Criteria:<br><br> 1. age <75y, male patients<br><br> 2. According to the 2017 Revised WHO Classification criteria for lymphoma, the subject<br> was diagnosed with DLBCL<br><br> 3. According to Ann Arbor staging, patients were classified as stage III-IV patients<br><br> 4. No previous anti-tumor systemic therapy or local radiation therapy for DLBCL<br><br> 5. Expected survival =6 months<br><br> 6. Have sufficient coagulation function and liver and kidney function<br><br> 7. Haver sufficient bone marrow function<br><br> 8. All patients should take medically approved contraceptive measures within 12 months<br> after rituximab administration (specific circumstances should follow the listed drug<br> label)<br><br> 9. Subjects were enrolled voluntarily, signed informed consent, and followed the<br> experimental treatment protocol and visit plan<br><br>Key Exclusion Criteria:<br><br> 1. Subjects assessed by the investigator to be intolerant to the R-CHOP regimen and/or<br> any drug therapy;<br><br> 2. Any previous anti-lymphoma systemic therapy or local radiation therapy<br><br> 3. Consider patients with lymphoma involving the central nervous system (CNS) or<br> diagnosed with primary CNS lymphoma (PCNSL); The diagnosis was primary mediastinal<br> large B-cell lymphoma (PMBL)<br><br> 4. Previously received organ transplantation or hematopoietic stem cell transplantation<br><br> 5. Had received major surgery or major trauma within 4 weeks before the first<br> medication (or before randomization), and had participated in clinical trials of<br> non-anti-tumor drugs or medical devices within 4 weeks<br><br> 6. Have had malignant tumors other than the indications targeted in this study in the<br> past three years<br><br> 7. Participants with any serious and/or uncontrolled systemic disease who are<br> determined by the investigator to be unsuitable for participation in the study<br><br> 8. Major cardiovascular disease occurred within 6 months before the first medication<br> (or before randomization)<br><br> 9. Any conditions that affect the patient's ingestion of the drug, as well as<br> conditions that seriously affect the absorption or pharmacokinetic parameters of the<br> drug in the trial, including difficult to control nausea and vomiting, short bowel<br> syndrome, etc.<br><br> 10. Subjects who received live or attenuated vaccine within 4 weeks prior to initial<br> administration (or prior to randomization) or planned to receive live vaccine during<br> the study period or 4 weeks after the end of study treatment<br><br> 11. A hemorrhagic disease (such as von Willebrand disease or hemophilia A, hemophilia B,<br> etc.) or according to the judgment of the investigator has a clear bleeding tendency<br><br> 12. have a serious peripheral nervous system or central nervous system disease.<br><br> 13. Warfarin or other vitamin K antagonists are required during the study<br><br> 14. There is an autoimmune disease that cannot be controlled or requires treatment<br> within 4 weeks prior to the first dose (or prior to randomization)<br><br> 15. Doxorubicin has been used in the past =150 mg/m2<br><br> 16. The investigator believes that the subjects have other conditions that are not<br> suitable for participation in this experiment.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MODIFIED-PFS
- Secondary Outcome Measures
Name Time Method Overall survival (OS);Complete response rate (CRR);Objective response rate (ORR)