Reduced‑dose apixaban or rivaroxaban versus daily low‑molecular‑weight heparin for people with blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, open‑label, three‑arm trial randomizing about 100 patients with active hematologic malignancies in a 1:1:1 ratio to apixaban 2.5 mg twice daily, rivaroxaban 10 mg once daily, or standard‑dose LMWH (enoxaparin 40 mg subcutaneously once daily). The primary outcome is the incidence of symptomatic or objectively confirmed venous thromboembolism during six months of follow‑up. Secondary outcomes include major and clinically relevant non‑major bleeding events, treatment adherence, and overall survival at six months. The trial targets patients starting systemic therapy who meet a Khorana score ≥2 and applies standard laboratory and organ‑function exclusion criteria.

Why it matters

Who can join: the full rules

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).

Where it's running

• Department of Haematology & Transplantology
  Gdansk, Pomeranian Voivodeship, Poland Recruiting

Study contacts

• Study coordinator: Agata Ogłoza-Puchowska, MD
• Email: a.ogloza@gumed.edu.pl
• Phone: +48 58 584 43 40

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.