Reduced‑dose apixaban or rivaroxaban versus daily low‑molecular‑weight heparin for people with blood cancers
Efficacy and Safety of Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies: A Prospective Randomized Study
This trial will test whether reduced‑dose apixaban or rivaroxaban pills can prevent blood clots as well and as safely as daily low‑molecular‑weight heparin injections in people with hematologic malignancies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Gdansk Academic / other |
| Locations | 1 site (Gdansk, Pomeranian Voivodeship) |
| Trial ID | NCT07270263 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with active hematologic malignancy starting systemic therapy who require primary thromboprophylaxis, have a Khorana score ≥2, adequate renal and hepatic function, platelets and hemoglobin above the exclusion thresholds, ECOG 0–2, and expected survival ≥6 months.
Not a fit: People with recent or active major bleeding, very low hemoglobin or platelets, severely reduced kidney or liver function, mechanical heart valves, or expected survival under six months are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, this approach could give patients a more convenient oral option for preventing clots that may match or improve safety compared with daily injections.
How similar studies have performed: Direct oral anticoagulants have shown efficacy for VTE prevention and treatment in patients with solid tumors in prior trials, but evidence in hematologic malignancies remains limited and less well established.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Gdansk, Pomeranian Voivodeship
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.