A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase
Summary
The purpose of this study is to compare the effect of a blood thinning drug called Apixaban versus no administration of a blood thinning drug, in preventing blood clots in children with leukemia or lymphoma. Patients must be receiving chemotherapy, including asparaginase, and have a central line (a catheter inserted for administration of medications and blood sampling)
Timeline
- Start
- 2015-10-22
- Primary completion
- 2021-07-07
- Completion
- 2021-07-07
Outcome
Mixed primary results
registry COUNT_OF_PARTICIPANTS Apixaban: 31 Participants NCT02369653 ↗
registry COUNT_OF_PARTICIPANTS Standard of Care: 45 Participants NCT02369653 ↗
registry analysis (superiority test); Apixaban vs Standard of Care; p = 0.0403; Cochran-Mantel-Haenszel NCT02369653 ↗
registry COUNT_OF_PARTICIPANTS Apixaban: 2 Participants NCT02369653 ↗
registry COUNT_OF_PARTICIPANTS Standard of Care: 2 Participants NCT02369653 ↗
registry analysis (superiority test); Apixaban vs Standard of Care; p = 1.0000; Cochran-Mantel-Haenszel NCT02369653 ↗
Publications
- Rodriguez V, O'Brien SH, Orgel E, Schultz CL, Esbenshade AJ, Memaj A, Dyme JL, Favatella NA, Mitchell LG. Safety and efficacy of apixaban thrombosis prevention in pediatric patients with obesity and acute lymphoblastic leukemia. Blood Adv. 2025 Sep 23;9(18):4738-4747. doi: 10.1182/bloodadvances.2025016160.
- O'Brien SH, Rodriguez V, Lew G, Newburger JW, Schultz CL, Orgel E, Derr K, Ranalli MA, Esbenshade AJ, Hochberg J, Kang HJ, Dinikina Y, Mills D, Donovan M, Dyme JL, Favatella NA, Mitchell LG; PREVAPIX-ALL investigators. Apixaban versus no anticoagulation for the prevention of venous thromboembolism in children with newly diagnosed acute lymphoblastic leukaemia or lymphoma (PREVAPIX-ALL): a phase 3, open-label, randomised, controlled trial. Lancet Haematol. 2024 Jan;11(1):e27-e37. doi: 10.1016/S2352-3026(23)00314-9. Epub 2023 Nov 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apixaban | Small molecule | 2.5 mg | Oral |