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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02369653




Registration number
NCT02369653
Ethics application status
Date submitted
21/01/2015
Date registered
24/02/2015
Date last updated
7/07/2020

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
2014-000328-47
Secondary ID [2] 0 0
CV185-155
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 0 0
Acute Lymphoblastic Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Apixaban
Other interventions - No systemic anticoagulant prophylaxis

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


Treatment: Drugs: Apixaban


Other interventions: No systemic anticoagulant prophylaxis


Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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 - Objectively confirmed by independent adjudication
Timepoint [1] 0 0
Up to 1 month
Primary outcome [2] 0 0
Safety: Adjudicated major bleeding using the International Society on Thrombosis and Haemostasis (ISTH) definition for children
Timepoint [2] 0 0
Up to 1 month
Secondary outcome [1] 0 0
Efficacy: a) Non-fatal asymptomatic DVT
Timepoint [1] 0 0
Up to 1 month
Secondary outcome [2] 0 0
Efficacy: b) Non-fatal symptomatic DVT
Timepoint [2] 0 0
Up to 1 month
Secondary outcome [3] 0 0
Efficacy: c) Non-fatal PE
Timepoint [3] 0 0
Up to 1 month
Secondary outcome [4] 0 0
Efficacy: d) CSVT
Timepoint [4] 0 0
Up to 1 month
Secondary outcome [5] 0 0
Efficacy: e) VTE-related-death
Timepoint [5] 0 0
Up to 1 month
Secondary outcome [6] 0 0
Safety: Composite of major and clinically relevant non major bleeding (CRNMB) using the ISTH definition for children
Timepoint [6] 0 0
Up to 1 month
Secondary outcome [7] 0 0
Pharmacodynamics: Anti-FXa Activity measured by plasma concentration assay
Timepoint [7] 0 0
Up to 1 month
Secondary outcome [8] 0 0
Pharmacokinetics: Measured by maximum observed concentration (Cmax)
Timepoint [8] 0 0
Up to 1 month
Secondary outcome [9] 0 0
Pharmacokinetics: Measured by trough observed concentration (Cmin)
Timepoint [9] 0 0
Up to 1 month
Secondary outcome [10] 0 0
Pharmacokinetics: Measured by area under the concentration-time curve in one dosing interval [AUC(TAU)]
Timepoint [10] 0 0
Up to 1 month

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com



- 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.
Minimum age
1 Year
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - New Lambton Heights
Recruitment hospital [2] 0 0
Queensland Children?s Hospital - Sth Brisbane
Recruitment hospital [3] 0 0
Monash Medical Centre Clayton - Clayton
Recruitment hospital [4] 0 0
Local Institution - Parkville
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
4101 - Sth Brisbane
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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Connecticut
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Delaware
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District of Columbia
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Georgia
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Illinois
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Indiana
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Iowa
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Kentucky
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Louisiana
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Maine
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Maryland
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Michigan
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Minnesota
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Mississippi
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Montana
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North Carolina
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Oregon
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Pennsylvania
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Tennessee
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West Virginia
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Wisconsin
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Belgium
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Bruxelles
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Belgium
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Edegem
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Gent
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Belgium
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Leuven
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Brazil
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Minas Gerais
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Brazil
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Parana
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Brazil
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RIO Grande DO SUL
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Brazil
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SAO Paulo
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Brazil
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Sao Paulo
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Canada
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Alberta
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Canada
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Newfoundland and Labrador
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Ontario
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Canada
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Calgary
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Czechia
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Brno
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Budapest
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Hungary
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Debrecen
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Hungary
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Pecs
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Korea, Republic of
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Seoul
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Distrito Federal
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Jalisco
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Christchurch
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Lublin
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Wroclaw
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Zabrze
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Puerto Rico
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Caguas
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Russian Federation
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Kirov
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Russian Federation
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Moscow
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Russian Federation
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St.petersburg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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)
Trial website
https://clinicaltrials.gov/show/NCT02369653
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02369653