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Xisomab 3G3 for the Prevention of Catheter-Associated Thrombosis in Patients With Cancer Receiving Chemotherapy | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT04465760•OHSU Knight Cancer Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed
•In consultation with principal investigator (PI) and treating physician, participant's cancer-directed therapy allows for a 1-day period between administration of study drug and subsequent start of planned cancer-directed therapy
•Individuals with a confirmed solid malignancy that are scheduled to undergo insertion of a PICC line or indwelling central venous catheter as part of planned anticancer therapy per institutional standards
•Must have Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
•Platelet count \> 100 x 10\^9/L
•Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Participants of childbearing potential are defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal
•Female participants of childbearing potential must agree to use adequate methods of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year without an alternative medical cause
•Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy
•Previously documented hypersensitivity to either the drug or excipients
•Psychiatric illness/social situations, or any other condition, that in the opinion of the investigator, would limit compliance with study requirements
+3 more criteria

Exclusion Criteria

•Actively receiving treatment in another therapeutic clinical trial
•Active acute leukemia (lymphoma and myeloma are allowed)
•At time of enrollment, known contraindication to anticoagulation therapy, including:
•* Clinically significant active bleeding
•* Individual is within 72 hours of major surgery
•* Abnormal baseline coagulation tests, including international normalized ratio (INR) \> 1.5, or activated partial thromboplastin time (aPTT) prolonged
•* Abnormal renal function defined by an estimated glomerular filtration rate (eGFR) \< 45 mL/min
•* Abnormal hepatic function defined as liver function tests (LFTs) (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\] or total bilirubin) \> 2 x the upper limit of normal or known Child-Pugh class B or C cirrhosis
•* Prior history of intracranial hemorrhage
•* Primary brain tumors or known brain metastasis
+6 more criteria

Locations (1)

OHSU Knight Cancer Institute

Portland, Oregon, United States

Key Dates

Start Date

February 25, 2021

Primary Completion Date

October 5, 2021

Completion Date

November 5, 2021

Last Updated

January 24, 2024

Enrollment

ACTUAL participants

Conditions

LymphomaMalignant Solid NeoplasmPlasma Cell Myeloma

Interventions

Xisomab 3G3

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial)

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma