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

ConditionsLymphomaLeukemiaMultiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), LymphomaVenous Thromboembolic DiseaseVTE (Venous Thromboembolism)PE - Pulmonary EmbolismHematologic Malignacies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Gdansk

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Apixaban

    Drug

    Oral tablet, 2.5 mg twice daily, for at least 6 months.

  • Rivaroxaban

    Drug

    Oral tablet, 10 mg once daily, for at least 6 months.

  • low molecular weight heparin (enoxaparin sodium)

    Drug

    Subcutaneous injection, 40 mg once daily (or equivalent), for at least 6 months.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: APIXABAN (reduced dose)Experimental treatment 1 intervention
Group B: RIVAROXABAN (reduced dose)Experimental treatment 1 intervention
Group C: Low-Molecular-Weight Heparin (LMWH)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months from randomization
2

Incidence of Major Bleeding (ISTH criteria)

Number of patients experiencing major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH).

Time frame
6 months from randomization
3

Incidence of Clinically Relevant Non-Major Bleeding (CRNMB)

Number of patients experiencing clinically relevant non-major bleeding (CRNMB) according to ISTH definition.

Time frame
6 months from randomization

Secondary outcomes

1

Overall Survival

Proportion of patients alive at 6 months after randomization.

Time frame
6 months
2

Treatment Discontinuation Due to Adverse Events

Number of patients who discontinued study drug due to adverse events, including bleeding and intolerance.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Gdansk

Lead sponsor

Source ClinicalTrials.gov
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