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Monoclonal Antibodies
Xisomab 3G3 for Blood Clot Prevention in Cancer Patients
Phase 2
Waitlist Available
Led By Joseph Shatzel, M.D.
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from xisomab 3g3 infusion up to end of treatment visit (day 18)
Awards & highlights
Study Summary
This trial studies xisomab 3G3 to see how well it works in preventing blood clots in cancer patients with catheters.
Who is the study for?
This trial is for adults with solid cancers like lymphoma or multiple myeloma who need a central venous catheter for chemotherapy. They must be in fairly good health, not on blood thinners, and have no major bleeding risks or recent thrombosis. Women of childbearing age must test negative for pregnancy and agree to use contraception.Check my eligibility
What is being tested?
The study tests Xisomab 3G3's effectiveness at preventing blood clots in patients with cancer receiving chemo through a catheter. It's a phase II trial where the drug, an antibody designed to stop clots from forming around the catheter site, will be given before starting standard cancer therapy.See study design
What are the potential side effects?
Potential side effects of Xisomab 3G3 may include allergic reactions due to hypersensitivity to the drug or its components. Since it aims to prevent clotting, there might also be an increased risk of bleeding complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from xisomab 3g3 infusion up to end of treatment visit (day 18)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from xisomab 3g3 infusion up to end of treatment visit (day 18)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Catheter-associated Thrombosis (CAT)
Secondary outcome measures
Incidence of Major and Clinically-relevant Bleeding
Incidence of Xisomab 3G3-associated Adverse Events (AEs)
Other outcome measures
Proportion of Patients That Had a Catheter Occlusion Requiring Medical Intervention
Quantification of Coagulation Measures: Activated Partial Thromboplastin Time (aPTT)
Quantification of Coagulation Measures: Platelet Count
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Supportive Care (xisomab 3G3)Experimental Treatment1 Intervention
Patients 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.
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Who is running the clinical trial?
OHSU Knight Cancer InstituteLead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently getting treatment in another research study.You have a type of blood cancer called acute leukemia that is currently active.You are scheduled to have a PICC line or central venous catheter inserted as part of your cancer treatment.You should be able to carry out light physical activities without needing help from others.Your platelet count is higher than 100 billion per liter.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive Care (xisomab 3G3)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to enroll in this medical experiment?
"According to clinicaltrials.gov, this investigation is actively seeking participants and was initially posted on February 25th 2021 with a recent update occurring on October 10th 2022."
Answered by AI
How many individuals are actively engaged in this medical experiment?
"Correct. Information posted on clinicaltrials.gov demonstrates that this medical experiment, which was first put up on February 25th 2021, is currently looking for participants. Approximately 50 individuals need to be recruiter from one centre."
Answered by AI
To what extent might Xisomab 3G3 pose a risk to individuals?
"Owing to its Phase 2 status, Xisomab 3G3 has received a rating of 2 for safety on our team's scale. This is due to the existing data supporting its security but no evidence of efficacy yet being available."
Answered by AI
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