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
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ClinicalTrials.gov Identifier: NCT02369653 |
Recruitment Status :
Recruiting
First Posted : February 24, 2015
Last Update Posted : October 23, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma Acute Lymphoblastic Leukemia | Drug: Apixaban Other: No systemic anticoagulant prophylaxis | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 500 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 |
Actual Study Start Date : | April 9, 2015 |
Estimated Primary Completion Date : | November 1, 2021 |
Estimated Study Completion Date : | November 15, 2021 |

Arm | Intervention/treatment |
---|---|
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 |
Drug: Apixaban |
Placebo Comparator: No systemic anticoagulant prophylaxis
No systemic anticoagulant prophylaxis
|
Other: No systemic anticoagulant prophylaxis |
- 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 ]Objectively confirmed by independent adjudication
- Safety: Adjudicated major bleeding using the International Society on Thrombosis and Haemostasis (ISTH) definition for children [ Time Frame: Up to 1 month ]
- Efficacy: a) Non-fatal asymptomatic DVT [ Time Frame: Up to 1 month ]
- Efficacy: b) Non-fatal symptomatic DVT [ Time Frame: Up to 1 month ]
- Efficacy: c) Non-fatal PE [ Time Frame: Up to 1 month ]
- Efficacy: d) CSVT [ Time Frame: Up to 1 month ]
- Efficacy: e) VTE-related-death [ Time Frame: Up to 1 month ]
- Safety: Composite of major and clinically relevant non major bleeding (CRNMB) using the ISTH definition for children [ Time Frame: Up to 1 month ]
- Pharmacodynamics: Anti-FXa Activity measured by plasma concentration assay [ Time Frame: Up to 1 month ]
- Pharmacokinetics: Measured by maximum observed concentration (Cmax) [ Time Frame: Up to 1 month ]
- Pharmacokinetics: Measured by trough observed concentration (Cmin) [ Time Frame: Up to 1 month ]
- Pharmacokinetics: Measured by area under the concentration-time curve in one dosing interval [AUC(TAU)] [ Time Frame: Up to 1 month ]

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Ages Eligible for Study: | 1 Year to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369653
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: | Clinical.Trials@bms.com | ||
Contact: First line of the email MUST contain NCT# and Site #. |

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT02369653 |
Other Study ID Numbers: |
CV185-155 2014-000328-47 ( EudraCT Number ) |
First Posted: | February 24, 2015 Key Record Dates |
Last Update Posted: | October 23, 2020 |
Last Verified: | October 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Anticoagulation |
Lymphoma Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Apixaban Anticoagulants Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |