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

Launched by XIA YI · Aug 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for male patients with advanced diffuse large B-cell lymphoma (DLBCL), a type of blood cancer. Researchers want to find out if using a higher dose of a medication called rituximab, combined with a standard chemotherapy regimen known as CHOP, can help patients live longer without their disease getting worse compared to the standard dose of rituximab. This trial is specifically for men aged 18 to 75 who have just been diagnosed with stage III or IV DLBCL and have not received any previous treatment for this condition.

Participants in the trial will receive either the high-dose treatment or the standard treatment, and they will be monitored over time to see how well each approach works. To be eligible, patients need to have good overall health, including functioning liver and kidney systems, and must not have other serious medical conditions that could affect their treatment. It's important that participants understand the study’s requirements and provide informed consent before joining. Overall, this trial aims to improve treatment options for men facing this challenging cancer.

Gender

MALE

Eligibility criteria

• Key Inclusion Criteria:
• • 1. age \<75y, male patients
• • 2. According to the 2017 Revised WHO Classification criteria for lymphoma, the subject was diagnosed with DLBCL
• • 3. According to Ann Arbor staging, patients were classified as stage III-IV patients
• • 4. No previous anti-tumor systemic therapy or local radiation therapy for DLBCL
• • 5. Expected survival ≥6 months
• • 6. Have sufficient coagulation function and liver and kidney function
• • 7. Haver sufficient bone marrow function
• • 8. All patients should take medically approved contraceptive measures within 12 months after rituximab administration (specific circumstances should follow the listed drug label)
• • 9. Subjects were enrolled voluntarily, signed informed consent, and followed the experimental treatment protocol and visit plan
• Key Exclusion Criteria:
• • 1. Subjects assessed by the investigator to be intolerant to the R-CHOP regimen and/or any drug therapy;
• • 2. Any previous anti-lymphoma systemic therapy or local radiation therapy
• • 3. Consider patients with lymphoma involving the central nervous system (CNS) or diagnosed with primary CNS lymphoma (PCNSL); The diagnosis was primary mediastinal large B-cell lymphoma (PMBL)
• • 4. Previously received organ transplantation or hematopoietic stem cell transplantation
• • 5. Had received major surgery or major trauma within 4 weeks before the first medication (or before randomization), and had participated in clinical trials of non-anti-tumor drugs or medical devices within 4 weeks
• • 6. Have had malignant tumors other than the indications targeted in this study in the past three years
• • 7. Participants with any serious and/or uncontrolled systemic disease who are determined by the investigator to be unsuitable for participation in the study
• • 8. Major cardiovascular disease occurred within 6 months before the first medication (or before randomization)
• • 9. Any conditions that affect the patient's ingestion of the drug, as well as conditions that seriously affect the absorption or pharmacokinetic parameters of the drug in the trial, including difficult to control nausea and vomiting, short bowel syndrome, etc.
• • 10. Subjects who received live or attenuated vaccine within 4 weeks prior to initial administration (or prior to randomization) or planned to receive live vaccine during the study period or 4 weeks after the end of study treatment
• • 11. A hemorrhagic disease (such as von Willebrand disease or hemophilia A, hemophilia B, etc.) or according to the judgment of the investigator has a clear bleeding tendency
• • 12. have a serious peripheral nervous system or central nervous system disease.
• • 13. Warfarin or other vitamin K antagonists are required during the study
• • 14. There is an autoimmune disease that cannot be controlled or requires treatment within 4 weeks prior to the first dose (or prior to randomization)
• • 15. Doxorubicin has been used in the past ≥150 mg/m2
• • 16. The investigator believes that the subjects have other conditions that are not suitable for participation in this experiment.