Xisomab 3G3 for the Prevention of Catheter-Associated Thrombosis in Patients With Cancer Receiving Chemotherapy
Condition: Lymphoma; Malignant Solid Neoplasm; Plasma Cell Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Thrombosis
Intervention: Xisomab 3G3
Intervention description: Given IV or via catheter
Intervention MeSH terms: Antibodies; Immunoglobulins
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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

        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

               -  Major extracranial bleed within the last 6 months where the cause has not been
                  identified or treated

               -  Known bleeding diathesis

               -  Use of therapeutic anticoagulation or anti-platelet agents for any indication at
                  enrollment

               -  At the discretion of the investigator, any other contraindication to
                  anticoagulation therapy

               -  Presence of a pediatric-sized PICC line

               -  Participant is expected to receive chemotherapy associated with a 15% or higher
                  incidence of grade 3-4 thrombocytopenia within 14 days of receiving study drug

          -  Preexisting intravenous catheter, or indwelling spinal or epidural catheter, at time
             of enrollment that is intended to remain for the duration of study. Participants may
             remain eligible if existing catheter is to be removed before placement of a catheter
             for cancer directed therapy. Removal of existing catheter should occur at least 24
             hours prior to PICC or indwelling catheter insertion

          -  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

          -  Participant is pregnant or breastfeeding, or expecting to conceive or father children
             within the projected duration of the trial, starting with the screening visit through
             90 days after the last dose of trial treatment

          -  Participant is allergic to heparin or heparin derivatives

          -  Participants with a history of venous thromboembolism within the last 3 months