Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Apixaban, Rivaroxaban, low molecular weight heparin (enoxaparin sodium).
- Who it may be relevant to
- Registry conditions: Lymphoma, Leukemia, Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma, Venous Thromboembolic Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
Interventions
- Drug Apixaban
Oral tablet, 2.5 mg twice daily, for at least 6 months. - Drug Rivaroxaban
Oral tablet, 10 mg 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.
Primary outcome measures
- Incidence of Venous Thromboembolism (VTE) [Time frame: 6 months from randomization]
- Incidence of Major Bleeding (ISTH criteria) [Time frame: 6 months from randomization]
- Incidence of Clinically Relevant Non-Major Bleeding (CRNMB) [Time frame: 6 months from randomization]
Secondary outcome measures (2)
- Overall Survival [Time frame: 6 months]
- Treatment Discontinuation Due to Adverse Events [Time frame: 6 months]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Poland · 1 center
- Department of Haematology & Transplantology — Gdansk
Identifiers
NCT: NCT07270263 · GUM-HEM-DOAC-2025-01