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
Purpose
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)
Conditions
- Lymphoma
- Acute Lymphoblastic Leukemia
Eligibility
- Eligible Ages
- Between 1 Year and 17 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 < 18 (17 years and 364 days) years.
Exclusion Criteria
- Subjects scheduled to have > 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 < 30% of normal for age and size as determined by the Schwartz formula - International normalized ratio (INR) > 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Apixaban |
Children aged 1 to <18 years weighing 6 to <35 kg randomized to apixaban will receive a fixed dose apixaban based on body weight tier twice a day for approximately 28 days. Children aged 1 to <18 years weighing ≥ 35 kg will receive 2.5 mg of apixaban twice a day for approximately 28 days. Subjects ≥ 5 years may be administered either 2.5-mg, 0.5-mg tablets or oral solution apixaban. Subjects < 5years and < 35 kg may be administered 0.5-mg tablets only |
|
|
Placebo Comparator No systemic anticoagulant prophylaxis |
No systemic anticoagulant prophylaxis |
|
More Details
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb