LymphomaHEM-DOACNCT07270263
Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies
A study testing Apixaban, Rivaroxaban and low molecular weight heparin (enoxaparin sodium) in people with Lymphoma and Leukemia, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
This study investigates the efficacy and safety of direct oral anticoagulants (DOACs) in comparison with standard low-molecular-weight heparin (LMWH) for the prevention of venous thromboembolism in patients with hematological malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Leukemia, Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma
- What is being tested?
- Apixaban, Rivaroxaban and low molecular weight heparin (enoxaparin sodium)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 22 Nov 2024to 31 Dec 2026
- Phase
- Interventional
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
- Active hematologic malignancy at the time of initiation of systemic therapy, including multiple myeloma, myeloproliferative neoplasm, lymphoma or other hematologic cancer with a Khorana score ≥ 2 points (intermediate or high risk of venous thromboembolism, VTE)
- Use of anticoagulant agents for primary thromboprophylaxis, including direct oral anticoagulants (DOACs) at reduced doses (apixaban 2.5 mg twice daily or rivaroxaban 10 mg once daily) or low-molecular-weight heparin (LMWH) (enoxaparin 40 mg subcutaneously once daily).
Who cannot join
- Major bleeding within the last month (including gastrointestinal or intracranial bleeding).
- Active major bleeding.
- Hemoglobin concentration < 8 g/dL.
- Thrombocytopenia with platelet count <30 × 10⁹/L.
- ECOG performance status of 3 or 4.
- Expected survival <6 months.
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- History of mechanical heart valve or severe mitral stenosis.
- Estimated glomerular filtration rate (eGFR) < 25 mL/min.
- Hepatic impairment (ALT ≥ 3× upper limit of normal or bilirubin ≥ 2× upper limit of normal).
- Acute coronary syndrome or ischemic stroke within the last 6 months.
- Anticipated significant drug-drug interactions between DOACs and anticancer agents.
- Known antiphospholipid syndrome (APS).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ewa Lewicka, Professor contact
Poland1 site, 1 recruiting
- Recruiting
Department of Haematology & Transplantology
Gdansk, Pomeranian Voivodeship, 80-152
Agata Ogłoza-Puchowska, MD, Principle Investigator, +48 58 584 43 40, a.ogloza@gumed.edu.pl
Ewa Lewicka, Professor, e.lewicka@gumed.edu.pl
About this study
Official title: Efficacy and Safety of Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies: A Prospective Randomized Study
This study investigates the efficacy and safety of direct oral anticoagulants (DOACs) in comparison with standard low-molecular-weight heparin (LMWH) for the prevention of venous thromboembolism in patients with hematological malignancies. Eligible participants will be randomized to receive reduced-dose apixaban, reduced-dose rivaroxaban, or standard-dose LMWH. The primary objective is to evaluate the incidence of venous thromboembolism during a 6-month follow-up period. Secondary objectives include assessment of bleeding complications, overall survival, and treatment adherence. The results of this study may provide evidence for safer and more convenient thromboprophylaxis strategies in patients with blood cancers.
Read the detailed description
Patients with hematologic malignancies are at high risk of developing venous thromboembolism (VTE). Low-molecular-weight heparin (LMWH) is currently the standard of care for thromboprophylaxis in this population; however, daily subcutaneous administration is burdensome and may impair adherence. Direct oral anticoagulants (DOACs), such as apixaban and rivaroxaban, have demonstrated efficacy in the prevention and treatment of VTE in patients with solid tumors, but data in hematologic malignancies are limited.
This study is designed as a prospective, randomized, open-label, parallel-group trial to compare the efficacy and safety of reduced-dose apixaban and rivaroxaban with standard-dose LMWH in patients with hematologic malignancies requiring primary thromboprophylaxis.
Approximately 100 patients will be randomized in a 1:1:1 ratio to receive:
Apixaban 2.5 mg orally twice daily, Rivaroxaban 10 mg orally once daily, or LMWH (enoxaparin 40 mg subcutaneously once daily or equivalent). The primary endpoint is the incidence of symptomatic or objectively confirmed VTE within 6 months of randomization. Secondary endpoints include major and clinically relevant non-major bleeding events (as defined by ISTH), treatment adherence, and overall survival at 6 months.
This study aims to address the unmet clinical need for optimized, patient-friendly thromboprophylaxis in hematologic malignancies and to provide high-quality data that may guide future clinical practice.
- Conditions
- Lymphoma, Leukemia, Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma, Venous Thromboembolic Disease, VTE (Venous Thromboembolism), PE - Pulmonary Embolism
- Being tested
- Apixaban, Rivaroxaban, low molecular weight heparin (enoxaparin sodium)
- Keywords
- Apixaban, Rivaroxaban, Low-Molecular-Weight Heparin, Venous Thromboembolism, Cancer-Associated Thrombosis, Hematologic Malignancies, Direct Oral Anticoagulants
- Medical subject headings
- Lymphoma, Leukemia, Multiple Myeloma, Venous Thromboembolism, Pulmonary Embolism, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called Eliquis, Poltixa
Oral tablet, 2.5 mg twice daily, for at least 6 months.
RivaroxabanDrug
Also called Xarelto, Mibrex, Zarixa
Oral tablet, 10 mg once daily, for at least 6 months.
low molecular weight heparin (enoxaparin sodium)Drug
Also called Clexane, Neoparin
Subcutaneous injection, 40 mg once daily (or equivalent), for at least 6 months.
| Study group | Role | What they receive |
|---|---|---|
| APIXABAN (reduced dose) | Experimental | Participants receive apixaban 2.5 mg orally twice daily for at least 6 months. Receives: Drug: Apixaban |
| RIVAROXABAN (reduced dose) | Experimental | Participants receive rivaroxaban 10 mg orally once daily for at least 6 months. Receives: Drug: Rivaroxaban |
| Low-Molecular-Weight Heparin (LMWH) | Active comparator | Participants receive low-molecular-weight heparin, 40 mg subcutaneously once daily for at least 6 months. Receives: Drug: low molecular weight heparin (enoxaparin sodium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Venous Thromboembolism (VTE)
Number of patients who develop symptomatic or incidental venous thromboembolism (deep vein thrombosis or pulmonary embolism) confirmed by objective imaging during the study treatment period.
Measured: 6 months from randomization
Incidence of Major Bleeding (ISTH criteria)
Number of patients experiencing major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH).
Measured: 6 months from randomization
Incidence of Clinically Relevant Non-Major Bleeding (CRNMB)
Number of patients experiencing clinically relevant non-major bleeding (CRNMB) according to ISTH definition.
Measured: 6 months from randomization
Secondary outcomes (2)
Overall Survival
Proportion of patients alive at 6 months after randomization.
Measured: 6 months
Treatment Discontinuation Due to Adverse Events
Number of patients who discontinued study drug due to adverse events, including bleeding and intolerance.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start22 Nov 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:1:1 ratio to receive reduced-dose apixaban, reduced-dose rivaroxaban, or standard low-molecular-weight heparin.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270263
- Sponsor's protocol ID
- GUM-HEM-DOAC-2025-01
- Acronym
- HEM-DOAC
- Status last verified
- Oct 2025
- First submitted
- 25 Nov 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this is a non-commercial, single-center academic study with no external data sharing agreements in place.