Phase 3
Completed N=512
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
Source: ClinicalTrials.gov NCT02369653 ↗Enrolled (actual)
512
Serious AEs
34.0%
Results posted
Mar 2022
Primary outcomePrimary: The Number of Participants With Non-Fatal DVT, PE, and CVST, and VTE-Related-Death — 31; 45 Participants — p=0.0403
◆ Published Evidence
Established
47citations · ~24 / year
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.
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)
Linked Publications (2)
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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.
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Safety and efficacy of apixaban thrombosis prevention in pediatric patients with obesity and acute lymphoblastic leukemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With Non-Fatal DVT, PE, and CVST, and VTE-Related-Death |
31; 45 | 0.0403 sig |
| PRIMARY The Number of Participants With Adjudicated Major Bleeding |
2; 2 | 1.0000 |
| SECONDARY The Number of Participants With Non-fatal Asymptomatic Deep Vein Thromboses (DVT) |
27; 38 | — |
| SECONDARY The Number of Participants With Non-fatal Symptomatic Deep Vein Thromboses (DVT) |
4; 6 | — |
| SECONDARY The Number of Participants With Non-fatal Pulmonary Embolism (PE) |
0; 0 | — |
| SECONDARY The Number of Participants With Cerebral Venous Sinus Thrombosis (CVST) |
0; 1 | — |
| SECONDARY The Number of Participants With Venous Thromboembolism (VTE)-Related-death |
0; 0 | — |
| SECONDARY The Number of Participants With Major and Clinically Relevant Non-Major Bleeding (CRNMB) |
13; 5 | — |
| SECONDARY The Number of Participant Deaths |
1; 3 | — |
| SECONDARY The Number of Participants With an Arterial Thromboembolic Event |
0; 0 | — |
| SECONDARY The Number of Participants With a CVAD-Related Infection |
1; 6 | — |
| SECONDARY The Number of Participants Needing Catheter Replacements During the Study |
3; 2 | — |
| SECONDARY The Number of Participants With CVAD Patency Restoration Events After Thrombolytic Therapy Use |
0; 0 | — |
| SECONDARY The Number Participants Experiencing Superficial Vein Thrombosis Events |
4; 2 | — |
| SECONDARY The Number of Participants With Clinically Relevant Non-Major Bleeding Events (CRNMB) |
11; 3 | — |
| SECONDARY The Number of Participants With Minor Bleeding Events |
37; 20 | — |
| SECONDARY The Number of Platelet Transfusions Needed During the Study |
266; 248 | — |
| SECONDARY Maximum Observed Concentration (Cmax) |
56.5; 63.6; 61.4; 54.2 | — |
| SECONDARY Trough Observed Concentration (Cmin) |
18.8; 18.1; 12; 12.9 | — |
| SECONDARY Area Under the Concentration-Time Curve [AUC(TAU)] |
470; 510; 453; 416 | — |
| SECONDARY Anti-FXa Activity |
55.3; 62.2; 52.8; 44.2; 78.7; 72.1 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- New diagnosis of de novo ALL, lymphomas (T or B cell), or mixed-phenotype acute leukemia
- Planned 3-4 drug systemic induction chemotherapy with a corticosteroid, vincristine and a single dose or multiple doses of asparaginase, with or without daunorubicin
- Functioning Central Venous Access Device
- Must be able to tolerate oral medication or have it administered via an Nasogastric tube (NGT) or GT tube
- Males and females, age 1 year(365 days) to 3 Lumbar Punctures over the course of the study treatment period
- Prior history of documented DVT or PE in the past 3 months
- Known inherited bleeding disorder or coagulopathy
- Major surgery [excluding Central Venous Access Device (CVAD) replacement and bone marrow aspiration and non-open biopsy] within the last 7 days prior to enrollment that may be associated with a risk of bleeding. Open biopsy is considered a major surgery.
- Uncontrolled severe hypertension at enrollment. Severe hypertension is defined as a systolic or diastolic blood pressure (BP) > 5 mm Hg above the 95th percentile as defined by the National High Blood Pressure Education Program Working Group (NHBPEP) established guidelines for the definition of normal and elevated blood pressure in children
- Extreme hyperleukocytosis, white blood cell (WBC) counts over 200 x 109/L (200,000/microL) at the time of enrollment
- Liver dysfunction manifested by SGTP (ALT) > 5X Upper limit of normal (ULN) and/or Aspartate aminotransferase (AST) >5 X ULN and/or direct (conjugated) bilirubin > 2X ULN
- Renal function 1.4 and activated partial thromboplastin time (aPTT) > 3 seconds above the upper limit of normal for age, within 1 week prior to enrollment.
- History of allergy to apixaban or Factor Xa inhibitors
- History of significant adverse reaction or major bleeding related adverse reaction to other anticoagulant or antiplatelet agents
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity
- Any investigational drug being administered during the study
Other protocol inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02369653) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.