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Monoclonal Antibodies
Abelacimab vs Dalteparin for Blood Clot Prevention in Cancer Patients (MAGNOLIA Trial)
Phase 3
Recruiting
Research Sponsored by Anthos Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Anticoagulation therapy with LMWH for at least 6 months is indicated
Confirmed GI or GU cancers if unresectable, locally advanced, metastatic, or non-metastatic and no intended curative surgery during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
MAGNOLIA Trial Summary
This trial will compare the effectiveness of two drugs for preventing blood clots in cancer patients.
Who is the study for?
This trial is for adults with gastrointestinal or genitourinary cancer who have had a recent deep vein thrombosis or pulmonary embolism. They must be able to take blood thinners for at least 6 months and not have any planned major surgery, brain trauma, severe liver issues, uncontrolled high blood pressure, or a life expectancy under 3 months.Check my eligibility
What is being tested?
The study compares Abelacimab to Dalteparin in preventing blood clot recurrence and managing bleeding risks in patients with certain cancers. It's an open-label trial where the effects of each treatment are evaluated by researchers unaware of which group participants belong to.See study design
What are the potential side effects?
Potential side effects may include bleeding complications, allergic reactions to medication components, possible liver enzyme elevations, and other organ-specific inflammation due to the anticoagulant nature of both Abelacimab and Dalteparin.
MAGNOLIA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on blood thinner medication for at least 6 months.
Select...
My GI or GU cancer cannot be surgically removed, is advanced, or has spread.
MAGNOLIA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to first event of centrally adjudicated VTE recurrence consisting of new proximal deep venous thrombosis, new pulmonary embolism (PE) or fatal PE, including unexplained death for which PE cannot be ruled out
Secondary outcome measures
Net clinical benefit defined as survival without VTE recurrence, or major or CRNM bleeding
Hemorrhage
MAGNOLIA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AbelacimabExperimental Treatment1 Intervention
Abelacimab intravenous administration followed by monthly administration of the same dose subcutaneously
Group II: DalteparinActive Control1 Intervention
Dalteparin administered subcutaneously daily
Find a Location
Who is running the clinical trial?
Anthos Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
14,783 Total Patients Enrolled
1 Trials studying Deep Vein Thrombosis
1,655 Patients Enrolled for Deep Vein Thrombosis
ItreasUNKNOWN
1 Previous Clinical Trials
1,655 Total Patients Enrolled
1 Trials studying Deep Vein Thrombosis
1,655 Patients Enrolled for Deep Vein Thrombosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with a blood clot in my leg or lung within the last 5 days.I have had a blood clot in my lung that affected my heart's ability to pump blood.I have been on blood thinners for more than 5 days.I have had bleeding that needed medical attention in the last 4 weeks.I have brain cancer or untreated cancer spread to the brain.I am allergic to the study drug or similar medications.I am not scheduled for any major surgery in the next 4 weeks.You have had a condition called heparin-induced thrombocytopenia in the past.I have severe health problems and spend most of my time in bed or a chair.I am a woman who can have children and will not or cannot use effective birth control during the study.I agree to use reliable contraception if I am sexually active.I haven't taken any experimental drugs recently.My blood pressure is not controlled even with medication.I do not have severe liver issues or significantly high liver enzyme levels.I have not had a stroke or brain bleed in the last 4 weeks.I have been on blood thinner medication for at least 6 months.My GI or GU cancer cannot be surgically removed, is advanced, or has spread.I have not had brain or spinal surgery or procedures in the last 4 weeks.I need to keep taking blood thinners for reasons other than blood clots.I am 18 years old or older.Your hemoglobin level is less than 8 grams per deciliter at the screening visit.My kidney function is low, with a creatinine clearance under 30 mL/min.I have had a procedure or treatment for a blood clot.I do not have an ongoing heart infection.I take more than 100 mg/day of aspirin or another drug to prevent blood clots.You are not expected to live for more than 3 months.Your platelet count is less than 50,000 per cubic millimeter at the screening visit.
Research Study Groups:
This trial has the following groups:- Group 1: Abelacimab
- Group 2: Dalteparin
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
What are the common purposes for taking Abelacimab?
"Abelacimab is commonly used to treat venous thromboembolism. This medication is also useful for patients with deep vein thrombosis, general surgery, and hemodialysis."
Answered by AI
Are there any serious dangers associated with taking Abelacimab?
"Abelacimab is estimated to be a 3 on a scale of 1-3 in terms of safety. This is due to it being a Phase 3 trial, which contains data supporting both its efficacy and safety from multiple rounds of testing."
Answered by AI
What else is Abelacimab being trialed for?
"Abelacimab is being researched in 14 different ongoing trials, 4 of which are in Phase 3. The majority of these trials are based out of Detroit, Michigan, but there are 469 locations running clinical trials for Abelacimab across the globe."
Answered by AI
Does this research project have room for new test subjects?
"That is accurate, the clinical trial indicated on clinicaltrials.gov is currently looking for participants. The first posting was on 7/29/2022 and the most recent update was on 7/18/2022. They are enrolling 1020 people total from 1 location."
Answered by AI
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