Xisomab 3G3 for the Prevention of Catheter-Associated Thrombosis in Patients With Cancer Receiving Chemotherapy

Lymphoma Clinical Trial

Official title: A Phase II Study of Xisomab 3G3, a Monoclonal Antibody Preventing the Activation of FXI by FXIIa, for the Prophylaxis of Catheter-Associated Thrombosis

Status Terminated

Clinical Trial Summary

This phase II trial studies how well xisomab 3G3 works in preventing catheter-associated blood clots (thrombosis) in patients with cancer receiving chemotherapy. Many patients with cancer develop blood clots from their catheters and can have pain, swelling, and other symptoms. They also often require blood thinners, which can increase the risk of bleeding. Xisomab 3G3 is type of drug called a monoclonal antibody that may prevent blood clots caused by a catheter in patients receiving chemotherapy.

Clinical Trial Description

PRIMARY OBJECTIVE I. To determine the efficacy of xisomab as measured by the incidence of catheter-associated thrombosis (CAT) in individuals with a central venous catheter. SECONDARY OBJECTIVE: I. To evaluate the safety and tolerability of xisomab 3G3 in cancer patients with a PICC or indwelling catheter. EXPLORATORY OBJECTIVE: I. Assessment of drug exposure and catheter occlusions leading to medical intervention. OUTLINE: Patients receive xisomab 3G3 intravenously (IV) or via catheter within 48 hours of catheter placement. Patients then receive standard of care chemotherapy 2 days later. After approximately 2 weeks, patients undergo standard of care ultrasound for possible CAT. After completion of study, patients are followed up for 60 days. ;

Related Conditions & MeSH terms

• Lymphoma
• Malignant Solid Neoplasm
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Myeloma
• Thrombosis

• NCT number: NCT04465760
• Study type: Interventional
• Source: OHSU Knight Cancer Institute
• Status: Terminated
• Phase: Phase 2
• Start date: February 25, 2021
• Completion date: November 5, 2021