Trial Review

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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02369653
Ethics application status
Date submitted
21/01/2015
Date registered
24/02/2015
Date last updated
8/03/2022

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
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Number of Participants With Non-Fatal DVT, PE, and CVST, and VTE-Related-Death
Timepoint [1] 0 0
From first dose up to approximately 40 days after first dose
Primary outcome [2] 0 0
The Number of Participants With Adjudicated Major Bleeding
Timepoint [2] 0 0
From first dose up to approximately 34 days after first dose
Secondary outcome [1] 0 0
The Number of Participants With Non-fatal Asymptomatic Deep Vein Thromboses (DVT)
Timepoint [1] 0 0
From first dose up to approximately 40 days after first dose
Secondary outcome [2] 0 0
The Number of Participants With Non-fatal Symptomatic Deep Vein Thromboses (DVT)
Timepoint [2] 0 0
From first dose up to approximately 34 days after first dose
Secondary outcome [3] 0 0
The Number of Participants With Non-fatal Pulmonary Embolism (PE)
Timepoint [3] 0 0
From first dose up to approximately 34 days after first dose
Secondary outcome [4] 0 0
The Number of Participants With Cerebral Venous Sinus Thrombosis (CVST)
Timepoint [4] 0 0
From first dose up to approximately 34 days after first dose
Secondary outcome [5] 0 0
The Number of Participants With Venous Thromboembolism (VTE)-Related-death
Timepoint [5] 0 0
From first dose up to approximately 34 days after first dose
Secondary outcome [6] 0 0
The Number of Participants With Major and Clinically Relevant Non-Major Bleeding (CRNMB)
Timepoint [6] 0 0
From first dose up to approximately 34 days after first dose
Secondary outcome [7] 0 0
The Number of Participant Deaths
Timepoint [7] 0 0
From first dose date until the end of the treatment period + 30 days (Up to approximately 59 days)
Secondary outcome [8] 0 0
The Number of Participants With an Arterial Thromboembolic Event
Timepoint [8] 0 0
From first dose up to approximately 34 days after first dose
Secondary outcome [9] 0 0
The Number of Participants With a CVAD-Related Infection
Timepoint [9] 0 0
From first dose up to approximately 34 days after first dose
Secondary outcome [10] 0 0
The Number of Participants Needing Catheter Replacements During the Study
Timepoint [10] 0 0
From first dose up to approximately 34 days after first dose
Secondary outcome [11] 0 0
The Number of Participants With CVAD Patency Restoration Events After Thrombolytic Therapy Use
Timepoint [11] 0 0
From first dose up to approximately 34 days after first dose
Secondary outcome [12] 0 0
The Number Participants Experiencing Superficial Vein Thrombosis Events
Timepoint [12] 0 0
From first dose up to approximately 34 days after first dose
Secondary outcome [13] 0 0
The Number of Participants With Clinically Relevant Non-Major Bleeding Events (CRNMB)
Timepoint [13] 0 0
From first dose up to approximately 34 days after first dose
Secondary outcome [14] 0 0
The Number of Participants With Minor Bleeding Events
Timepoint [14] 0 0
From first dose up to approximately 34 days after first dose
Secondary outcome [15] 0 0
The Number of Platelet Transfusions Needed During the Study
Timepoint [15] 0 0
From first dose up to approximately 34 days after first dose
Secondary outcome [16] 0 0
Maximum Observed Concentration (Cmax)
Timepoint [16] 0 0
pre-dose, 1-4 hours post dose
Secondary outcome [17] 0 0
Trough Observed Concentration (Cmin)
Timepoint [17] 0 0
pre-dose, 1-4 hours post dose
Secondary outcome [18] 0 0
Area Under the Concentration-Time Curve [AUC(TAU)]
Timepoint [18] 0 0
pre-dose, 1-4 hours post dose
Secondary outcome [19] 0 0
Anti-FXa Activity
Timepoint [19] 0 0
pre-dose and 2.5 hours after dosing on day 7. Day 8 and day 15.

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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/07/2021
Sample size
Target
Accrual to date
Final
512
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Mississippi
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Belgium
State/province [25] 0 0
Bruxelles
Country [26] 0 0
Belgium
State/province [26] 0 0
Edegem
Country [27] 0 0
Belgium
State/province [27] 0 0
Gent
Country [28] 0 0
Belgium
State/province [28] 0 0
Leuven
Country [29] 0 0
Canada
State/province [29] 0 0
Alberta
Country [30] 0 0
Canada
State/province [30] 0 0
Newfoundland and Labrador
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Czechia
State/province [32] 0 0
Brno
Country [33] 0 0
Hungary
State/province [33] 0 0
Budapest
Country [34] 0 0
Hungary
State/province [34] 0 0
Debrecen
Country [35] 0 0
Hungary
State/province [35] 0 0
Pecs
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Seoul
Country [37] 0 0
Mexico
State/province [37] 0 0
Distrito Federal
Country [38] 0 0
Mexico
State/province [38] 0 0
Jalisco
Country [39] 0 0
Mexico
State/province [39] 0 0
Nuevo Leon
Country [40] 0 0
New Zealand
State/province [40] 0 0
Christchurch
Country [41] 0 0
Poland
State/province [41] 0 0
Wroclaw
Country [42] 0 0
Poland
State/province [42] 0 0
Zabrze
Country [43] 0 0
Puerto Rico
State/province [43] 0 0
Caguas
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Kirov
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Moscow
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Saint Petersburg
Country [47] 0 0
Russian Federation
State/province [47] 0 0
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02369653