NCT04465760

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lymphoma
• Malignant Solid Neoplasm
• Plasma Cell Myeloma

Interventions

Type	Name	Description
DRUG	Xisomab 3G3	Given IV or via catheter

Timeline

• Start date: 2021-02-25
• Primary completion: 2021-10-05
• Completion: 2021-11-05
• First posted: 2020-07-10
• Last updated: 2024-01-24
• Results posted: 2024-01-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study