Abelacimab vs Dalteparin for Blood Clot Prevention in Cancer Patients

(MAGNOLIA Trial)

Recruiting in Palo Alto (17 mi)

+116 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Anthos Therapeutics, Inc.

Must be taking: Anticoagulants

Must not be taking: Antiplatelets, Fibrinolytics

Disqualifiers: Stroke, Brain cancer, Hypertension, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial compares a new medication, Abelacimab, to another treatment, Dalteparin, in patients with GI or GU cancer who have had blood clots. The goal is to see which treatment better prevents new clots and reduces bleeding risks.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you do not have an indication to continue treatment with other anticoagulants besides those for VTE treatment. If you are on other anticoagulants for conditions like atrial fibrillation, you may need to stop them.

What data supports the effectiveness of the drug Abelacimab for blood clot prevention in cancer patients?

Abelacimab is a novel drug that targets Factor XI, which is involved in blood clotting, and offers a promising approach to prevent blood clots without causing excessive bleeding. While specific data on Abelacimab's effectiveness in cancer patients is limited, similar drugs like Factor Xa inhibitors have shown effectiveness in reducing blood clot recurrence in cancer patients, suggesting potential benefits for Abelacimab as well. ^{1 2 3 4 5}

Is Abelacimab (MAA868) safe for humans?

Abelacimab (MAA868) is a new type of medication that targets a specific part of the blood clotting process, and it has been studied for its safety in humans. While specific safety data for cancer patients is not detailed, it is designed to prevent blood clots without causing excessive bleeding, which suggests a focus on safety. Dalteparin, another medication used for blood clot prevention, has been shown to have a low rate of severe bleeding in cancer patients. ^{1 2 3 6 7}

How does the drug Abelacimab differ from Dalteparin for preventing blood clots in cancer patients?

Abelacimab is unique because it targets Factor XI, a different part of the blood clotting process, whereas Dalteparin is a low-molecular-weight heparin that works by inhibiting Factor Xa. This difference in mechanism may offer an alternative for patients who need a different approach to blood clot prevention. ^{1 4 5 7 8}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I was diagnosed with a blood clot in my leg or lung within the last 5 days.

Able to provide written informed consent

I have been on blood thinner medication for at least 6 months.

Exclusion Criteria

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.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either abelacimab monthly or dalteparin daily for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Abelacimab (Monoclonal Antibodies)
• Dalteparin (Anticoagulant)

Trial Overview 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.

Participant Groups

Group I: Abelacimab Experimental Treatment 1 Intervention

Abelacimab intravenous administration followed by monthly administration of the same dose subcutaneously

Group II: Dalteparin Active Control 1 Intervention

Dalteparin administered subcutaneously daily

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Calgary Calgary, Canada

Barnes-Jewish Hospital Saint Louis, MO

Ottawa Hospital Research Instituite Ottawa, Canada

Memorial Sloan Kettering Cancer Center-Middletown Middletown, NJ

More Trial Locations

Who Is Running the Clinical Trial?

Anthos Therapeutics, Inc.

Lead Sponsor

Trials

6

Patients Recruited

6,600+

Itreas

Collaborator

Trials

2

Patients Recruited

2,700+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Modern anticoagulation with factor Xa inhibitors in oncology: is the gastrointestinal bleeding rate (also) decisive?] Raithel, M., Haibach, M., Kremenevski, I., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticoagulation with Factor Xa Inhibitors Is Associated with Improved Overall Response and Progression-Free Survival in Patients with Metastatic Malignant Melanoma Receiving Immune Checkpoint Inhibitors-A Retrospective, Real-World Cohort Study. Haist, M., Stege, H., Pemler, S., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and pharmacodynamics of Abelacimab (MAA868), a novel dual inhibitor of Factor XI and Factor XIa. Yi, BA., Freedholm, D., Widener, N., et al.[2023]

In the SELECT-D trial, rivaroxaban demonstrated lower rates of venous thromboembolism (VTE) recurrence compared to dalteparin, but it was associated with a higher risk of bleeding in cancer patients.

A cost-effectiveness analysis showed that rivaroxaban is economically dominant over dalteparin, potentially saving over €10 million annually for approximately 8000 cancer patients with VTE in the Netherlands, while also slightly improving patient health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness analysis and budget impact of rivaroxaban compared with dalteparin in patients with cancer at risk of recurrent venous thromboembolism. de Jong, LA., van der Velden, AWG., Hulst, MV., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The direct oral anticoagulants rivaroxaban and dabigatran do not inhibit orthotopic growth and metastasis of human breast cancer in mice. Buijs, JT., Laghmani, EH., van den Akker, RFP., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological reduction of coagulation factor XI reduces macrophage accumulation and accelerates deep vein thrombosis resolution in a mouse model of venous thrombosis. Jordan, KR., Wyatt, CR., Fallon, ME., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OC-11 - Anticoagulation therapy in selected cancer patients at risk of recurrence of venous thromboembolism. Young, A., Phillips, J., Hancocks, H., et al.[2016]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of cancer-associated venous thromboembolism: 12-month outcomes of the placebo versus rivaroxaban randomization of the SELECT-D Trial (SELECT-D: 12m). Marshall, A., Levine, M., Hill, C., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Modern anticoagulation with factor Xa inhibitors in oncology: is the gastrointestinal bleeding rate (also) decisive?] [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Anticoagulation with Factor Xa Inhibitors Is Associated with Improved Overall Response and Progression-Free Survival in Patients with Metastatic Malignant Melanoma Receiving Immune Checkpoint Inhibitors-A Retrospective, Real-World Cohort Study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and pharmacodynamics of Abelacimab (MAA868), a novel dual inhibitor of Factor XI and Factor XIa. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Cost-effectiveness analysis and budget impact of rivaroxaban compared with dalteparin in patients with cancer at risk of recurrent venous thromboembolism. [2021]

5. England pubmed.ncbi.nlm.nih.gov

The direct oral anticoagulants rivaroxaban and dabigatran do not inhibit orthotopic growth and metastasis of human breast cancer in mice. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Pharmacological reduction of coagulation factor XI reduces macrophage accumulation and accelerates deep vein thrombosis resolution in a mouse model of venous thrombosis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

OC-11 - Anticoagulation therapy in selected cancer patients at risk of recurrence of venous thromboembolism. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Treatment of cancer-associated venous thromboembolism: 12-month outcomes of the placebo versus rivaroxaban randomization of the SELECT-D Trial (SELECT-D: 12m). [2023]