Description:
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)
Title
- Brief Title: 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
- Official Title: A Phase III Randomized, Open Label, Multi-center Study of the Safety and Efficacy of Apixaban for Thromboembolism Prevention Versus No Systemic Anticoagulant Prophylaxis During Induction Chemotherapy in Children With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoma (T or B Cell) Treated With Asparaginase
Clinical Trial IDs
- ORG STUDY ID:
CV185-155
- SECONDARY ID:
2014-000328-47
- NCT ID:
NCT02369653
Conditions
- Lymphoma
- Acute Lymphoblastic Leukemia
Interventions
Drug | Synonyms | Arms |
---|
Apixaban | | Apixaban |
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)
Trial Arms
Name | Type | Description | Interventions |
---|
Apixaban | Experimental | 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 | |
No systemic anticoagulant prophylaxis | Placebo Comparator | No systemic anticoagulant prophylaxis | |
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 < 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
Maximum Eligible Age: | 17 Years |
Minimum Eligible Age: | 1 Year |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Efficacy: A composite of adjudicated non-fatal deep vein thrombosis (DVT, including asymptomatic and symptomatic), pulmonary embolism (PE), and cerebral venous sinus thrombosis (CSVT) and venous thromboembolism (VTE)-related-death |
Time Frame: | Up to 1 month |
Safety Issue: | |
Description: | Objectively confirmed by independent adjudication |
Secondary Outcome Measures
Measure: | Efficacy: a) Non-fatal asymptomatic DVT |
Time Frame: | Up to 1 month |
Safety Issue: | |
Description: | |
Measure: | Efficacy: b) Non-fatal symptomatic DVT |
Time Frame: | Up to 1 month |
Safety Issue: | |
Description: | |
Measure: | Efficacy: c) Non-fatal PE |
Time Frame: | Up to 1 month |
Safety Issue: | |
Description: | |
Measure: | Efficacy: d) CSVT |
Time Frame: | Up to 1 month |
Safety Issue: | |
Description: | |
Measure: | Efficacy: e) VTE-related-death |
Time Frame: | Up to 1 month |
Safety Issue: | |
Description: | |
Measure: | Safety: Composite of major and clinically relevant non major bleeding (CRNMB) using the ISTH definition for children |
Time Frame: | Up to 1 month |
Safety Issue: | |
Description: | |
Measure: | Pharmacodynamics: Anti-FXa Activity measured by plasma concentration assay |
Time Frame: | Up to 1 month |
Safety Issue: | |
Description: | |
Measure: | Pharmacokinetics: Measured by maximum observed concentration (Cmax) |
Time Frame: | Up to 1 month |
Safety Issue: | |
Description: | |
Measure: | Pharmacokinetics: Measured by trough observed concentration (Cmin) |
Time Frame: | Up to 1 month |
Safety Issue: | |
Description: | |
Measure: | Pharmacokinetics: Measured by area under the concentration-time curve in one dosing interval [AUC(TAU)] |
Time Frame: | Up to 1 month |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Trial Keywords
Last Updated
July 13, 2021