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LymphomaPhase 2NCT04465760

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

A Phase 2 study testing Xisomab 3G3 in people with Lymphoma and Malignant Solid Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Xisomab 3G3
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
25 Feb 2021to 5 Nov 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

Other trials in United States

About this study

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

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.

Read the 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:

  1. To evaluate the safety and tolerability of xisomab 3G3 in cancer patients with a PICC or indwelling catheter.

EXPLORATORY OBJECTIVE:

  1. 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.

Being tested
Xisomab 3G3
Medical subject headings
Lymphoma, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Xisomab 3G3Drug

    Also called AB 023, AB-023, AB023, Anti-factor XI Monoclonal Antibody Xisomab 3G3

    Given IV or via catheter

Study groups in NCT04465760
Study groupRoleWhat they receive
Supportive Care (xisomab 3G3)ExperimentalPatients receive xisomab 3G3 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.
Receives: Drug: Xisomab 3G3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Catheter-associated Thrombosis (CAT)

    The incidence of overall CAT (inclusive of both symptomatic and asymptomatic events) will be assessed and reported with 95% confidence interval.

    Measured: Up to end of treatment visit (day 18)

Secondary outcomes (2)

  1. Incidence of Major and Clinically-relevant Bleeding

    Bleeding will be defined using the International Society of Thrombosis and Hemostasis definition of major bleeding for clinical investigations of anti-hemostatic medicinal products in nonsurgical patients (i.e., fatal bleeding, critical organ bleeding such as central nervous system bleeding, or bleeding causing a fall in hemoglobin of 20 g/L or more) and clinically relevant non-major bleeding (i.e., bleeding that does not fit the former definition of major bleeding but prompts medical attention). The incidence of major and clinically relevant non-major bleeding, along with 95% confidence interval, will be assessed using the safety analysis set (all patients who are exposed to the single dose of study drug).

    Measured: Up to end of follow-up (60 days from time of administration)

  2. Incidence of Xisomab 3G3-associated Adverse Events (AEs)

    Descriptive statistics of safety will be presented using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 using the safety analysis set (all patients who are exposed to the single dose of study drug). All on-study AEs, treatment-related AEs, serious adverse events (SAEs), and treatment-related SAEs will be tabulated using worst grade per National Cancer Institute (NCI) CTCAE v5.0 criteria by system organ class and preferred term. On-study lab parameters including hematology, chemistry, liver function, and renal function will be summarized using worst grade NCI CTCAE v5.0 criteria.

    Measured: Up to end of follow-up (60 days from time of administration)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2020
  2. Study start25 Feb 2021
  3. Primary completion5 Oct 2021
  4. Study completion5 Nov 2021

Why it stopped: Insufficient accrual rate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04465760
Sponsor's protocol ID
STUDY00018976
Other IDs
NCI-2020-02554, STUDY00018976, R01HL151367
Status last verified
Jan 2024
First submitted
25 Jun 2020
Last updated
24 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Pfeffer MA, Kohs TCL, Vu HH, Jordan KR, Wang JSH, Lorentz CU, Tucker EI, Puy C, Olson SR, DeLoughery TG, Hinds MT, Keshari RS, Gailani D, Lupu F, McCarty OJT, Shatzel JJ. Factor XI Inhibition for the Prevention of Catheter-Associated Thrombosis in Patients With Cancer Undergoing Central Line Placement: A Phase 2 Clinical Trial. Arterioscler Thromb Vasc Biol. 2024 Jan;44(1):290-299. doi: 10.1161/ATVBAHA.123.319692. Epub 2023 Nov 16.

    PubMed 37970718

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Xisomab 3G3 in people with Lymphoma and Malignant Solid Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Catheter-associated Thrombosis (CAT) (time frame: Up to end of treatment visit (day 18)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04465760, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.

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