Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies (HEM-DOAC)

December 18, 2025 updated by: Medical University of Gdansk

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-152
        • Recruiting
        • Department of Haematology & Transplantology
        • Contact:
          • Agata Ogłoza-Puchowska, MD, Principle Investigator
          • Phone Number: +48 58 584 43 40
          • Email: a.ogloza@gumed.edu.pl
        • Contact:
        • Principal Investigator:
          • Agata Ogłoza-Puchowska, MD
        • Sub-Investigator:
          • Ewa Lewicka, Professor
        • Sub-Investigator:
          • Andrzej Mital, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: APIXABAN (reduced dose)
Participants receive apixaban 2.5 mg orally twice daily for at least 6 months.
Drug: Apixaban
Oral tablet, 2.5 mg twice daily, for at least 6 months.
Other Names:
  • Eliquis
  • Poltixa
Experimental: RIVAROXABAN (reduced dose)
Participants receive rivaroxaban 10 mg orally once daily for at least 6 months.
Drug: Rivaroxaban
Oral tablet, 10 mg once daily, for at least 6 months.
Other Names:
  • Xarelto
  • Mibrex
  • Zarixa
Active Comparator: Low-Molecular-Weight Heparin (LMWH)
Participants receive low-molecular-weight heparin, 40 mg subcutaneously once daily for at least 6 months.
Drug: low molecular weight heparin (enoxaparin sodium)
Subcutaneous injection, 40 mg once daily (or equivalent), for at least 6 months.
Other Names:
  • Clexane
  • Neoparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Venous Thromboembolism (VTE)
Time Frame: 6 months from randomization
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.
6 months from randomization
Incidence of Major Bleeding (ISTH criteria)
Time Frame: 6 months from randomization
Number of patients experiencing major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH).
6 months from randomization
Incidence of Clinically Relevant Non-Major Bleeding (CRNMB)
Time Frame: 6 months from randomization
Number of patients experiencing clinically relevant non-major bleeding (CRNMB) according to ISTH definition.
6 months from randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 6 months
Proportion of patients alive at 6 months after randomization.
6 months
Treatment Discontinuation Due to Adverse Events
Time Frame: 6 months
Number of patients who discontinued study drug due to adverse events, including bleeding and intolerance.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Estimated)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUM-HEM-DOAC-2025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma

Clinical Trials on Apixaban

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe