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Venous ThromboembolismPhase 3MAGNOLIANCT05171075

A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE

A Phase 3 study testing Abelacimab and Dalteparin in people with Venous Thromboembolism and Deep Venous Thrombosis, run by Anthos Therapeutics, Inc. at 117 sites in 20 countries.

Terminated

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

Official record
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Trial summary

This is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia) Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Abelacimab and Dalteparin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
417 participants
Where
117 sitesin 20 countries
Study dates
27 Sep 2022to 10 Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Male or female subjects ≥18 years old or other legal maturity age according to the country of residence
  • Confirmed GI (colorectal, pancreatic, gastric, esophageal, gastro-esophageal junction or hepatobiliary) or confirmed GU (renal, ureteral, bladder, prostate, or urethra) cancers if:
  • Unresectable, locally advanced, metastatic, or non-metastatic GI/GU cancer and
  • No intended curative surgery during the study
  • Confirmed symptomatic or incidental proximal lower limb deep vein thrombosis (DVT) (i.e., popliteal, femoral, iliac, and/or inferior vena cava vein thrombosis) and/or a confirmed symptomatic pulmonary embolism (PE), or an incidental PE in a segmental, or larger pulmonary artery. Patients are eligible within 120 hours from diagnosis of the qualifying VTE.
  • Anticoagulation therapy with LMWH for at least 6 months is indicated
  • Able to provide written informed consent

Who cannot join

  • Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) occurrence of DVT and/or PE
  • More than 120 hours of pre-treatment with therapeutic doses of UFH, LMWH, or other anticoagulants
  • An indication to continue treatment with therapeutic doses of an anticoagulant other than for VTE treatment prior to randomization (e.g., atrial fibrillation, mechanical heart valve, prior VTE)
  • PE leading to hemodynamic instability (systolic BP <90 mmHg or shock).
  • Acute ischemic or hemorrhagic stroke or intracranial hemorrhage, in the last 4 weeks preceding screening.
  • Brain trauma, or cerebral or a spinal cord surgery or spinal procedures such as lumbar puncture or epidural/spinal anesthesia within 4 weeks of screening
Show all 25Show fewer
  • Need for aspirin in a dosage of more than 100 mg/day or, any other antiplatelet agent alone or in combination with aspirin
  • Bleeding requiring medical attention at the time of randomization or in the preceding 4 weeks
  • Planned brain, spinal cord, cardiac, vascular, major thoracic and/or major abdominal surgery in the 4 weeks following randomization
  • History of heparin induced thrombocytopenia
  • Infective acute or subacute endocarditis at the time of presentation
  • Primary brain cancer or untreated intracranial metastasis
  • Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4 at screening
  • Life expectancy of <3 months at randomization
  • Calculated creatinine clearance (CrCl) <30 mL/min at the screening visit
  • Platelet count <50,000/ mm3 at the screening visit
  • Hemoglobin <8 g/dL at the screening visit
  • Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase ≥3 times and/or bilirubin ≥2 times the upper limit of normal (ULN) at the screening visit in the absence of clinical explanation
  • Uncontrolled hypertension (systolic blood pressure [BP] > 180 mm Hg or diastolic BP >100 mm Hg despite antihypertensive treatment)
  • Women of child-bearing potential (WOCBP) who are unwilling or unable to use highly effective contraceptive measures during the study from screening up to 3 days after last treatment of dalteparin or 100 days after administration of abelacimab
  • Sexually active males with sexual partners of childbearing potential must agree to use a condom or other reliable contraceptive measure up to 3 days after last treatment of dalteparin or 100 days after administration of abelacimab
  • Pregnant or breast-feeding women
  • History of hypersensitivity to any of the study drugs (including dalteparin) or its excipients, to drugs of similar chemical classes, or any contraindication listed in the label for dalteparin
  • Subjects with any condition that in the judgement of the Investigator would place the subject at increased risk of harm if he/she participated in the study
  • Use of other investigational (not-registered) drugs within 5 half-lives prior to enrollment or until the expected pharmacodynamic effect has returned to baseline, whichever is longer. Participation in academic non-interventional studies or interventional studies, comprising testing different strategies or different combinations of registered drugs is permitted.

Trial locations and contacts

117 sites in 20 countries.

117 sites in 20 countries

France16 sites

  • CHU Angers - Hôpital Hôtel Dieu

    Angers, 49933

  • CHU Clermont Ferrand - Hopital Gabriel Montpied

    Clermont-Ferrand, 63003

  • Hôpital Louis Mourier

    Colombes, Renouiflers, 92700

  • CH Le Puy en Velay

    Le Puy-en-Velay, Chantemesse, 43 000

  • CHU de Limoges - Hôpital Dupuytren

    Limoges, Cedex, 87042

  • CHU de Limoges - Hôpital Dupuytren

    Limoges, 87042

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75013

  • Hôpital Européen Georges Pompidou

    Paris, 75015

  • Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69310

  • CHU de Rouen - Hôpital de Bois Guillaume

    Rouen, 76031

  • CHU de Saint-Etienne - Hopital Nord

    Saint-Etienne, 42000

  • Nouvel Hôpital Civil de Strasbourg

    Strasbourg, Strasbourg, 67091

  • CHU Strasbourg - Nouvel Hôpital Civil

    Strasbourg, 67091

  • Centre Hospitalier Intercommunal de Toulon

    Toulon, 83000

  • CHU de Nancy - Hôpital de Brabois Adultes

    Vandœuvre-lès-Nancy, Rue Du Morvan, 54500

  • CHU de Nancy - Hôpital de Brabois Adultes

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain16 sites

  • Hospital Universitario Del Vinalopo

    Alicante, 03293

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital General Universitario de Elche

    Elche, 3203

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital Universitario Ciudad de Jaen

    Jaén, 23007

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Clinica Universidad de Navarra

    Madrid, 28027

  • MD Anderson Cancer Centre

    Madrid, 28033

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222

  • Complejo Hospitalario Universitario de Ourense

    Ourense

  • Hospital Universitario Central de Asturia

    Oviedo, 33011

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Corporacio Sanitaria Parc Tauli

    Sabadell, 8208

  • Hospital Universitario Marques de Valdecilla

    Santander, 39012

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

China13 sites

  • Beijing Shijitan Hosp.

    Beijing, 100038

  • Peking University Third Hospital

    Beijing, 100191

  • Jilin Province Tumor Hospital

    Ch’ang-ch’un, 130012

  • Southern Medical University - Zhujiang Hospital

    Guangdong, 510280

  • Nanfang Hospital of Southern Medical University

    Guangzhou, 510515

  • The Sixth Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, 510655

  • Huizhou Municipal Central Hospital

    Huizhou, 516001

  • Nanjing First Hospital

    Nanjing, 210006

  • Nantong Tumor Hospital (Tumor Hospital Affiliated to Nantong University )

    Tongzhou, 226361

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

  • Union Hospital Tongji Medical College Huazhong University of Science &Technology

    Wuhan, 430023

  • Hubei Cancer Hospital

    Wuhan, 430079

  • The Second Hospital of Jiaxing

    Zhejiang, 314000

Other trials in China

Italy13 sites

  • IRCCS Istituto Tumori Giovanni Paolo II

    Bari, 70124

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127

  • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

    Bologna, 40133

  • Presidio Ospedaliero di Castelfranco Veneto

    Castelfranco Veneto, 31033

  • SS. ma Annunziata

    Chieti, 66013

  • Ospedale Civile Dell Annunziata

    Cosenza, 87100

  • Ospedale Degli Infermi

    Faenza, 48018

  • Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo

    Milan, 20142

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131

  • Azienda Ospedale - Università Padova

    Padova, 35128

  • Ospedale Universitario

    Padova, 35128

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Ospedale San Bortolo di Vicenza

    Vicenza, 36100

Other trials in Italy

United States10 sites

  • Memorial Sloan Kettering Cancer Center-Commack

    Commack, New York, 11725

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • NorthShore University Health System

    Evanston, Illinois, 60201

  • Memorial Sloan Kettering Cancer Center-West Harrison

    Harrison, New York, 10604

  • Memorial Sloan Kettering Cancer Center-Middletown

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021-0005

  • Weill Cornell Medical College

    New York, New York, 10021

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Washington DC VAMC

    Washington D.C., District of Columbia, 20422

Other trials in United States

Netherlands8 sites

  • Meander Medisch Centrum

    Amersfoort, 3813

  • Albert Schweitzer Ziekenhuis, Dordwijk

    Dordrecht, 3317 NM

  • Spaarne Gasthuis (Kennemer Gasthuis) - Haarlem-Zuid

    Haarlem

  • Amsterdam University Medical Center

    Holland, 1105AZ

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6500

  • Ikazia Ziekenhuis

    Rotterdam, 3083 AN

  • Haga Ziekenhuis

    The Hague, 2545 AA

Other trials in Netherlands

Canada6 sites

  • University of Calgary

    Calgary, T2N1N4

  • Hamilton Health Sciences, Juravinski Hospital and Cancer Centre

    Hamilton, Ontario, L8V 1C3

  • Sault Area Hospital

    Marie, P6A0A8

  • Ottawa Hospital Research Instituite

    Ottawa, Ontario, K1H 8L6

  • Ottawa Hospital Research Instituite

    Ottawa, Ontario, K1H BL6

  • Toronto General Hospital

    Toronto, M5G 2C4

Other trials in Canada

Germany5 sites

  • Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt

    Dresden, 01067

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 1307

  • Praxis für Gefäßmedizin

    Görlitz, 2827

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitätsklinik Leipzig

    Leipzig, 4103

Other trials in Germany

Czechia4 sites

  • Masarykuv onkologicky ustav

    Brno, 65653

  • University Hospital Hradec Kralove

    Hradec Králové, 50005

  • Onkologická klinika VFN a 1. LF UK

    Prague, 128 08

  • Thomayerova nemocnice

    Prague, 14059

Other trials in Czechia

Australia3 sites

  • Blacktown Hospital

    Blacktown, New South Wales, 2148

  • Northern Health

    Epping, Victoria, 3076

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Ireland3 sites

  • Cork University Hospital

    Cork, T12 DC4A

  • Bon Secour Hospital

    Cork, T12 DV56

  • Beaumont Hospital

    Dublin, D09V2N0

Other trials in Ireland

Latvia3 sites

  • Daugavpils Regional Hospital

    Daugavpils, LV-5417

  • Liepaja Regional Hospital

    Liepāja, LV3414

  • Pauls Stradins CUH

    Riga, LV-1002

Other trials in Latvia

South Korea3 sites

  • Jeonbuk National University Hospital

    Jeonju, 54907

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Ewha Womans University Mokdong Hospital

    Seoul, 7985

Other trials in South Korea

Taiwan3 sites

  • Far Eastern Memorial Hospital

    New Taipei City, 220

  • National Cheng Kung University (NCKU) Hospital

    Tainan, 704

  • Tri-Service General Hospital

    Taipei, 11490

Other trials in Taiwan

United Kingdom3 sites

  • University Hospital of Wales

    Cardiff, England, CF14 4XW

  • Castle Hill Hospital, Department of Oncology & Haematology

    Cottingham, ENG, HU16 5JQ

  • The Newcastle Upon Tyne Hospitals

    Newcastle upon Tyne, ENG, NE7 7DN

Other trials in United Kingdom

Austria2 sites

  • LK Wiener Neustadt

    Neustadt, 2700

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

Hungary2 sites

  • Debreceni Egyetem

    Debrecen, 4032

  • Markhot Ferenc Oktatokorhaz es Rendelointezet

    Eger, H-3300

Other trials in Hungary

Norway2 sites

  • Østfold Hospital Kalnes

    Fredrikstad, 1603

  • Akershus Univeristy Hospital

    Lørenskog, 1478

Other trials in Norway

Sweden1 site

  • Länssjukhuset Sundsvall-Härnösand

    Sundsvall, 85186

Other trials in Sweden

Switzerland1 site

  • Hopital Universitaire Geneve

    Geneva, 1205

Other trials in Switzerland

About this study

Official title: A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab vs. Dalteparin on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With GI/GU Associated VTE

This is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia)

Read the detailed description

Cancer associated thrombosis (CAT) is a severe medical condition which is characterized by high incidence of Venous thromboembolism (VTE) recurrence and high risk for bleeding. Patients with intact GI and GU cancer have increased bleeding risk with oral direct anticoagulants (DOACs), Guidelines advice caution with those DOACs or state preference for low molecular weight heparin (LMWH) in this population. The ANT-008 study will compare treatment with abelacimab monthly administration to LMWH daily subcutaneous (sc) administration over 6-month treatment. The study outcomes include VTE recurrence, bleeding event and treatment discontinuation at 6 months

Being tested
Abelacimab, Dalteparin
Keywords
Anticoagulants, VTE recurrence rate, PROBE design, LMWH, CAT, Cancer associated VTE, GI cancer, Abelacimab, Dalteparin, GU cancer, FXI, Major bleeding events, CRNM bleeding events
Medical subject headings
Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism, Gastrointestinal Neoplasms

What participants receive

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

  • AbelacimabBiological

    Also called MAA868

    Abelacimab 150 mg

  • DalteparinDrug

    Also called Fragmin

    Dalteparin 200 IU/kg/day followed by 150 IU/kg/day

Study groups in NCT05171075
Study groupRoleWhat they receive
AbelacimabExperimentalAbelacimab intravenous administration followed by monthly administration of the same dose subcutaneously
Receives: Biological: Abelacimab
DalteparinActive comparatorDalteparin administered subcutaneously daily
Receives: Drug: Dalteparin

What is being measured

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

  1. Time to first event of centrally adjudicated VTE recurrence

    Time to first adjudicated venous thromboembolism (VTE) event recurrence

    Measured: up to 6 months

Secondary outcomes (8)

  1. Time to first event of ISTH-adjudicated major or clinically relevant non-major (CRNM) bleeding events

    Time to first adjudicated major or clinically relevant non-major (CRNM) bleeding event

    Measured: up to 6 months

  2. Time to first event of VTE recurrence, ISTH adjudicated major or ISTH-adjudicated CRNM bleeding events

    Time to first adjudicated venous thromboembolism (VTE) or bleeding event

    Measured: up to 6 months

  3. Time to event of permanent treatment discontinuation not due to death

    Time to permanent discontinuation not due to death

    Measured: up to 6 months

  4. Time to first event of ISTH-adjudicated CRNM bleeding events

    Time to first adjudicated clinically relevant non-major (CRNM) bleeding event

    Measured: up to 6 months

  5. Time to first event of ISTH-adjudicated major bleeding events

    Time to first adjudicated major bleeding event

    Measured: Up to 6 months

  6. Time to first event of GI ISTH-adjudicated major and GI CRNM bleeding events

    Time to first adjudicated gastrointestinal (GI) major and clinically relevant non-major (CRNM) bleeding event

    Measured: up to 6 months

  7. All-cause death, vascular death, serious adverse events, adverse events leading to drug discontinuation, other adverse events, abnormal lab tests, etc. presented as rate per 100 patient-years

    Measured: up to 6 months

  8. For patients treated with abelacimab: percent with injection site reactions/severity, hypersensitivity reactions/severity, anti-drug antibody formation, neutralizing antibody

    Measured: up to 6 months

Timeline

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

  1. First posted28 Dec 2021
  2. Study start27 Sep 2022
  3. Primary completion10 Apr 2026
  4. Study completion10 Apr 2026

Why it stopped: Sponsor Decision

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
417 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05171075
Sponsor's protocol ID
ANT-008
Other IDs
2021-003085-12, CMAA868D12301
Acronym
MAGNOLIA
Status last verified
Apr 2026
First submitted
22 Nov 2021
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abelacimab and Dalteparin in people with Venous Thromboembolism and Deep Venous Thrombosis, run by Anthos Therapeutics, Inc. at 117 sites in 20 countries.

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 7 inclusion and 25 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in France, Spain, China, Italy, United States and 15 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.

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?

Time to first event of centrally adjudicated VTE recurrence (time frame: up to 6 months). 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 NCT05171075.

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 17 Apr 2026.

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