Selinexor Combined With R-GDP Regimen for TP53-altered R/R DLBCL

Exclusion Criteria

• •1. Prior treatment with selinexor or another XPO1 inhibitor
• •2. There are contraindications to any drug in the combination therapy
• •3. Receipt of any standard or investigational anti-DLBCL therapy \<21 days before C1D1 (including non-palliative radiotherapy, chemotherapy, immunotherapy, radioimmunotherapy, or any other anticancer therapy) (Palliative radiotherapy for non-target lesions was allowed)
• •4. Undergone major surgery \<14 days before C1D1
• •5. Hematopoietic stem cell transplantation /CAR-T therapy requirements are as follows:
• •Autologous hematopoietic stem cell transplantation (HSCT) \<100 days or allogeneic HSCT \<180 days prior to C1D1 Active graft-versus-host disease (GVHD) after allogeneic HSCT (or inability to discontinue GVHD therapy or preventive therapy) CAR-T cell infusion \<90 days before cycle 1
• •6. Presence of grade ≥2 neuropathy (CTCAE, v.5.0)
• •7. Presence of any life-threatening disease, medical condition, or organ system dysfunction that is considered by the investigator to be likely affecting patient safety or adherence to study procedures
• •8. Uncontrolled (i.e., clinically unstable) infection within 7 days before the first dose of study treatment and required treatment with intravenous antibiotics, antiviral drugs or antifungal drugs; However, prophylactic use of these agents was allowed.
• •9. Patients with active HBV, HCV, or HIV infection. Participants who were HBsAg positive and/or HBcAb positive but HBV-DNA negative, and/or HCV antibody positive but HCV-RNA negative were allowed to participate (the upper limit of normal values for HBV-DNA and HCV-RNA were based on the values available at each participating center).
• •10. Inability to swallow tablets, presence of a malabsorption syndrome, or any other condition that may interfere with absorption of the study drug
• •11. Lactating or pregnant women
• •12. Unable or unwilling to sign the ICF
• •13. Patients who were considered by the investigator to be significantly below tolerable weight
• •14. Patients who received live attenuated vaccine within 28 days prior to the first dose of study treatment