LymphomaPhase 3NCT02369653
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
A Phase 3 study testing Apixaban and No systemic anticoagulant prophylaxis in people with Lymphoma and Acute Lymphoblastic Leukemia, run by Bristol-Myers Squibb at 96 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Lymphoma, Acute Lymphoblastic Leukemia
- What is being tested?
- Apixaban and No systemic anticoagulant prophylaxis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 512 participants
- Where
- 96 sitesin 12 countries
- Study dates
- 22 Oct 2015to 7 Jul 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
96 sites in 12 countries.
96 sites in 12 countries
United States64 sites
Akron Children'S Hospital
Akron, Ohio, 44308
Albany Medical Center
Albany, New York, 12208
University Of Michigan Cancer Center
Ann Arbor, Michigan, 48109
Childrens Healthcare Of Atlanta - E
Atlanta, Georgia, 30342
Dell Children'S Medical Center Of Central Texas
Austin, Texas, 78723
Sinai Hospital Of Baltimore
Baltimore, Maryland, 21215
Johns Hopkins University
Baltimore, Maryland, 21287
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
St. Luke'S Mountain State Tumor Institute
Boise, Idaho, 83712
Roswell Park Cancer Institute
Buffalo, New York, 14263
Unv. Of Nc At Chapel Hill
Chapel Hill, North Carolina, 27599
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, 45229-3039
University Hospitals
Cleveland, Ohio, 44106
Nationwide Children'S Hospital
Columbus, Ohio, 43205
Driscoll Children'S Hospital
Corpus Christi, Texas, 78411
Geisinger Medical Center
Danville, Pennsylvania, 17822
Blank Childrens Hospital
Des Moines, Iowa, 50309
City of Hope
Duarte, California, 91010
Golisano Childrens Hospital of Southwest Florida
Fort Myers, Florida, 33908
Shands Hospital At University Of Florida
Gainesville, Florida, 32610-0298
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Texas Children's Cancer and Hematology Centers
Houston, Texas, 77030
Children'S Center For Cancer And Blood Diseases
Indianapolis, Indiana, 46260
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University Of Mississippi Medical Center
Jackson, Mississippi, 39216
Nemours Children'S Clinic
Jacksonville, Florida, 32207
University of Kentucky
Lexington, Kentucky, 40536-0293
Loma Linda University Cancer Center
Loma Linda, California, 92350
Childrens Hospital Of La
Los Angeles, California, 90027
University Of Louisville
Louisville, Kentucky, 40202
Navicent Health Physician Group
Macon, Georgia, 31201
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Childrens Hospitals And Clinics Of Minnesota
Minneapolis, Minnesota, 55404
University Of Minnesota
Minneapolis, Minnesota, 55455
Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
Monroe Carell Jr Children'S Hosp. At Vanderbilt Tower
Nashville, Tennessee, 37232
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Yale University School Of Medicine
New Haven, Connecticut, 06520
Childrens Hospital New Orleans
New Orleans, Louisiana, 70118
Ochsner Medical Center
New Orleans, Louisiana, 70121
Children'S Hospital Of Orange County
Orange, California, 92868
Nemours Children'S Clinic - Orlando
Orlando, Florida, 32827
Lucile Packard Children's Hospital (LPCH)
Palo Alto, California, 94304
Valerie Fund Children's Center at St. Joseph's Children's Hospital
Paterson, New Jersey, 07503
Nemours Children'S Clinic-Pensacola
Pensacola, Florida, 32504
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104
Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr.
Phoenix, Arizona, 85016
Children's Hospital Of Pittsburgh Of UPMC
Pittsburgh, Pennsylvania, 15224
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University Of Rochester General Clinical Research Center
Rochester, New York, 14642
Children's Hospital of San Antonio
San Antonio, Texas, 78207
University Hospital
San Antonio, Texas, 78284
Rady Children'S Hospital - San Diego
San Diego, California, 92123-4282
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
All Childrens Hospital Specialty Physicians
St. Petersburg, Florida, 33701
SUNY Upstate Medical University
Syracuse, New York, 13210
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405
Scott & White - McLane Children's Specialty Clinic
Temple, Texas, 76502
New York Medical College
Valhalla, New York, 10595
St. Marys Medical Center
West Palm Beach, Florida, 33407
Nemours / A. I. duPont Hospital for Children
Wilmington, Delaware, 19803
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Belgium5 sites
Local Institution
Brussels, 1020
Local Institution
Brussels, 1200
Local Institution
Edegem, 2650
Local Institution
Ghent, 9000
Local Institution
Leuven, 3000
Canada5 sites
Alberta Children'S Hospital
Calgary, Alberta, T3B 6A8
Local Institution
Edmonton, Alberta, T6G 2B7
Children'S Hospital London Health Sciences Centre
London, Ontario, N6A 5W9
Children'S Hospital Of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Local Institution
St. John's, Newfoundland and Labrador, A1B 3V6
Russia5 sites
Local Institution
Kirov, 610027
Local Institution
Moscow, 115478
Local Institution
Moscow, 117198
Local Institution
Saint Petersburg, 197341
Local Institution
Saint Petersburg, 197758
Australia4 sites
Monash Medical Centre Clayton
Clayton, Victoria, 3168
Local Institution
New Lambton Heights, New South Wales, 2305
Local Institution
Parkville, Victoria, 3052
Queensland Children's Hospital
Sth Brisbane, Queensland, 4101
Hungary3 sites
Local Institution
Budapest, 1094
Local Institution
Debrecen, 4032
Local Institution
Pécs, 7623
Mexico3 sites
Local Institution
Df, Mexico City, 04530
Local Institution
Guadalajara, Jalisco, 44340
Local Institution
Monterrey, Nuevo León, 64460
Poland2 sites
Klinika Transplantacji Szpiku Onkologii i Hematologii Dzieciecej
Wroclaw, 50-556
Oddzial Hematologii i Onkologii Dzieciecej
Zabrze, 41-800
South Korea2 sites
Local Institution
Seoul, 03080
Local Institution
Seoul, 03722
About this study
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
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
- Being tested
- Apixaban, No systemic anticoagulant prophylaxis
- Keywords
- Anticoagulation
- Medical subject headings
- Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
No systemic anticoagulant prophylaxisOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Apixaban |
| No systemic anticoagulant prophylaxis | Placebo comparator | No systemic anticoagulant prophylaxis Receives: Other: No systemic anticoagulant prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants With Non-Fatal DVT, PE, and CVST, and VTE-Related-Death
The number of participants with non-fatal deep vein thromboses (DVT) (including asymptomatic and symptomatic), pulmonary embolism (PE), cerebral venous sinus thrombosis (CVST); and venous thromboembolism (VTE) related-death objectively confirmed by a blinded, independent adjudication committee.
Symptomatic events are included during the intended treatment period. Asymptomatic events are included from scans up to Day 40.
Measured: From first dose up to approximately 40 days after first dose
The Number of Participants With Adjudicated Major Bleeding
The number of participants with major bleeding adjudicated by a blinded, independent adjudication committee. Adjudicated major bleeding is defined as bleeding that satisfies one or more of the following criteria:
- fatal bleeding
- clinically overt bleeding associated with a decrease in hemoglobin of at least 20g/L (ie, 2g/dL) in a 24-hour period
- bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS; and/or
- bleeding that requires surgical intervention in an operating suite, including interventional radiology.
Measured: From first dose up to approximately 34 days after first dose
Secondary outcomes (19)
The Number of Participants With Non-fatal Asymptomatic Deep Vein Thromboses (DVT)
The number of participants with non-fatal asymptomatic deep vein thromboses (DVT) adjudicated by a blinded, independent adjudication committee
Measured: From first dose up to approximately 40 days after first dose
The Number of Participants With Non-fatal Symptomatic Deep Vein Thromboses (DVT)
The number of participants with non-fatal symptomatic deep vein thromboses (DVT) adjudicated by a blinded, independent adjudication committee
Measured: From first dose up to approximately 34 days after first dose
The Number of Participants With Non-fatal Pulmonary Embolism (PE)
The number of participants with non-fatal pulmonary embolism (PE) adjudicated by a blinded, independent adjudication committee
Measured: From first dose up to approximately 34 days after first dose
The Number of Participants With Cerebral Venous Sinus Thrombosis (CVST)
The number of participants with cerebral venous sinus thrombosis (CVST) adjudicated by a blinded, independent adjudication committee
Measured: From first dose up to approximately 34 days after first dose
The Number of Participants With Venous Thromboembolism (VTE)-Related-death
The number of participants with venous thromboembolism (VTE)-related-death adjudicated by a blinded, independent adjudication committee
Measured: From first dose up to approximately 34 days after first dose
The Number of Participants With Major and Clinically Relevant Non-Major Bleeding (CRNMB)
The number of participants with major and clinically relevant non-major bleeding (CRNMB) adjudicated by a blinded, independent adjudication committee
CRNM bleeding is defined as bleeding that satisfies one or both of the following:
- overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition and
- bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room
Measured: From first dose up to approximately 34 days after first dose
The Number of Participant Deaths
The number of participant deaths adjudicated by a blinded, independent adjudication committee
Measured: From first dose date until the end of the treatment period + 30 days (Up to approximately 59 days)
The Number of Participants With an Arterial Thromboembolic Event
The number of participants with an arterial thromboembolic event including paradoxical embolism and stroke adjudicated by a blinded, independent adjudication committee
Measured: From first dose up to approximately 34 days after first dose
The Number of Participants With a CVAD-Related Infection
The number of participants with a central venous access device (CVAD)-related infection adjudicated by a blinded, independent adjudication committee
Measured: From first dose up to approximately 34 days after first dose
The Number of Participants Needing Catheter Replacements During the Study
The number of participants needing catheter replacements during the study
Measured: From first dose up to approximately 34 days after first dose
The Number of Participants With CVAD Patency Restoration Events After Thrombolytic Therapy Use
The number of participants with central venous access device (CVAD) patency restoration events after thrombolytic therapy use
Measured: From first dose up to approximately 34 days after first dose
The Number Participants Experiencing Superficial Vein Thrombosis Events
The number participants experiencing superficial vein thrombosis events.
Clots that occur in a superficial vein ie, cephalic vein, basilic vein (upper extremity) or saphenous vein (lower extremity) confirmed by radiographic imaging.
Measured: From first dose up to approximately 34 days after first dose
The Number of Participants With Clinically Relevant Non-Major Bleeding Events (CRNMB)
The number of participants with clinically relevant non-major bleeding events (CRNMB) adjudicated by a blinded, independent adjudication committee.
CRNM bleeding is defined as bleeding that satisfies one or both of the following:
- overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition and
- bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room
Measured: From first dose up to approximately 34 days after first dose
The Number of Participants With Minor Bleeding Events
The number of participants with minor bleeding events adjudicated by a blinded, independent adjudication committee.
Minor bleeding defined as any overt or macroscopic evidence of bleeding that does not fulfill the criteria for either major bleeding or CRNMB
Measured: From first dose up to approximately 34 days after first dose
The Number of Platelet Transfusions Needed During the Study
The number of platelet transfusions needed during the study.
The events are not adjudicated. A subject could have more than one platelet transfusion.
Measured: From first dose up to approximately 34 days after first dose
Maximum Observed Concentration (Cmax)
The maximum observed concentration (Cmax) was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy.
Measured: pre-dose, 1-4 hours post dose
Trough Observed Concentration (Cmin)
The trough observed concentration (Cmin) was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy.
Measured: pre-dose, 1-4 hours post dose
Area Under the Concentration-Time Curve [AUC(TAU)]
The area under the concentration-time curve [AUC(TAU)] was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy.
Measured: pre-dose, 1-4 hours post dose
Anti-FXa Activity
Anti-FXa Activity was measured to characterize the relationship between apixaban plasma concentration and anti-FXa activity in pediatric subjects receiving induction chemotherapy
Measured: pre-dose and 2.5 hours after dosing on day 7. Day 8 and day 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study start22 Oct 2015
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369653
- Sponsor's protocol ID
- CV185-155
- Other IDs
- 2014-000328-47, 2014
- Status last verified
- Feb 2022
- First submitted
- 21 Jan 2015
- Last updated
- 8 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Rodriguez V, O'Brien SH, Orgel E, Schultz CL, Esbenshade AJ, Memaj A, Dyme JL, Favatella NA, Mitchell LG. Safety and efficacy of apixaban thrombosis prevention in pediatric patients with obesity and acute lymphoblastic leukemia. Blood Adv. 2025 Sep 23;9(18):4738-4747. doi: 10.1182/bloodadvances.2025016160.
PubMed 40505060Jarugula P, Ajavon-Hartmann T, Obianom O, Ludwig E, Crevar C, Marchisin D, Wang Z, Chen W, He B, Mitchell LG, Rodriguez V, Lew G, Perera V, Murthy B, Merali S. Modeling and Simulation to Inform Apixaban Dosing in Pediatrics With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Treated With Asparaginase. Clin Pharmacol Ther. 2025 Aug;118(2):355-364. doi: 10.1002/cpt.3616. Epub 2025 Apr 29.
PubMed 40302153O'Brien SH, Rodriguez V, Lew G, Newburger JW, Schultz CL, Orgel E, Derr K, Ranalli MA, Esbenshade AJ, Hochberg J, Kang HJ, Dinikina Y, Mills D, Donovan M, Dyme JL, Favatella NA, Mitchell LG; PREVAPIX-ALL investigators. Apixaban versus no anticoagulation for the prevention of venous thromboembolism in children with newly diagnosed acute lymphoblastic leukaemia or lymphoma (PREVAPIX-ALL): a phase 3, open-label, randomised, controlled trial. Lancet Haematol. 2024 Jan;11(1):e27-e37. doi: 10.1016/S2352-3026(23)00314-9. Epub 2023 Nov 16.
PubMed 37980924
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02369653
- Acronym / sponsor ID
- CV185-155
- Conditions
- Lymphoma, Acute Lymphoblastic Leukemia
- Keywords
- Anticoagulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 22 Oct 2015 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Posted 8 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apixaban | Experimental | Drug: ApixabanChildren 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 | Other: No systemic anticoagulant prophylaxisNo systemic anticoagulant prophylaxis |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apixaban | Drug | Apixaban |
| No systemic anticoagulant prophylaxis | Other | No systemic anticoagulant prophylaxis |
Primary outcome
The Number of Participants With Non-Fatal DVT, PE, and CVST, and VTE-Related-Death
Time frame: From first dose up to approximately 40 days after first dose
The number of participants with non-fatal deep vein thromboses (DVT) (including asymptomatic and symptomatic), pulmonary embolism (PE), cerebral venous sinus thrombosis (CVST); and venous thromboembolism (VTE) related-death objectively confirmed by a blinded, independent adjudication committee. Symptomatic events are included during the intended treatment period. Asymptomatic events are included from scans up to Day 40.
The Number of Participants With Adjudicated Major Bleeding
Time frame: From first dose up to approximately 34 days after first dose
The number of participants with major bleeding adjudicated by a blinded, independent adjudication committee. Adjudicated major bleeding is defined as bleeding that satisfies one or more of the following criteria: 1. fatal bleeding 2. clinically overt bleeding associated with a decrease in hemoglobin of at least 20g/L (ie, 2g/dL) in a 24-hour period 3. bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS; and/or 4. bleeding that requires surgical intervention in an operating suite, including interventional radiology.
19 secondary outcomes
The Number of Participants With Non-fatal Asymptomatic Deep Vein Thromboses (DVT)
Time frame: From first dose up to approximately 40 days after first dose
The Number of Participants With Non-fatal Symptomatic Deep Vein Thromboses (DVT)
Time frame: From first dose up to approximately 34 days after first dose
The Number of Participants With Non-fatal Pulmonary Embolism (PE)
Time frame: From first dose up to approximately 34 days after first dose
The Number of Participants With Cerebral Venous Sinus Thrombosis (CVST)
Time frame: From first dose up to approximately 34 days after first dose
The Number of Participants With Venous Thromboembolism (VTE)-Related-death
Time frame: From first dose up to approximately 34 days after first dose
The Number of Participants With Major and Clinically Relevant Non-Major Bleeding (CRNMB)
Time frame: From first dose up to approximately 34 days after first dose
The Number of Participant Deaths
Time frame: From first dose date until the end of the treatment period + 30 days (Up to approximately 59 days)
The Number of Participants With an Arterial Thromboembolic Event
Time frame: From first dose up to approximately 34 days after first dose
The Number of Participants With a CVAD-Related Infection
Time frame: From first dose up to approximately 34 days after first dose
The Number of Participants Needing Catheter Replacements During the Study
Time frame: From first dose up to approximately 34 days after first dose
The Number of Participants With CVAD Patency Restoration Events After Thrombolytic Therapy Use
Time frame: From first dose up to approximately 34 days after first dose
The Number Participants Experiencing Superficial Vein Thrombosis Events
Time frame: From first dose up to approximately 34 days after first dose
The Number of Participants With Clinically Relevant Non-Major Bleeding Events (CRNMB)
Time frame: From first dose up to approximately 34 days after first dose
The Number of Participants With Minor Bleeding Events
Time frame: From first dose up to approximately 34 days after first dose
The Number of Platelet Transfusions Needed During the Study
Time frame: From first dose up to approximately 34 days after first dose
Maximum Observed Concentration (Cmax)
Time frame: pre-dose, 1-4 hours post dose
Trough Observed Concentration (Cmin)
Time frame: pre-dose, 1-4 hours post dose
Area Under the Concentration-Time Curve [AUC(TAU)]
Time frame: pre-dose, 1-4 hours post dose
Anti-FXa Activity
Time frame: pre-dose and 2.5 hours after dosing on day 7. Day 8 and day 15.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40505060Rodriguez V, O'Brien SH, Orgel E, Schultz CL, Esbenshade AJ, Memaj A, Dyme JL, Favatella NA, Mitchell LG. Safety and efficacy of apixaban thrombosis prevention in pediatric patients with obesity and acute lymphoblastic leukemia. Blood Adv. 2025 Sep 23;9(18):4738-4747. doi: 10.1182/bloodadvances.2025016160.
- Derived from this study: PubMed 40302153Jarugula P, Ajavon-Hartmann T, Obianom O, Ludwig E, Crevar C, Marchisin D, Wang Z, Chen W, He B, Mitchell LG, Rodriguez V, Lew G, Perera V, Murthy B, Merali S. Modeling and Simulation to Inform Apixaban Dosing in Pediatrics With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Treated With Asparaginase. Clin Pharmacol Ther. 2025 Aug;118(2):355-364. doi: 10.1002/cpt.3616. Epub 2025 Apr 29.
- Derived from this study: PubMed 37980924O'Brien SH, Rodriguez V, Lew G, Newburger JW, Schultz CL, Orgel E, Derr K, Ranalli MA, Esbenshade AJ, Hochberg J, Kang HJ, Dinikina Y, Mills D, Donovan M, Dyme JL, Favatella NA, Mitchell LG; PREVAPIX-ALL investigators. Apixaban versus no anticoagulation for the prevention of venous thromboembolism in children with newly diagnosed acute lymphoblastic leukaemia or lymphoma (PREVAPIX-ALL): a phase 3, open-label, randomised, controlled trial. Lancet Haematol. 2024 Jan;11(1):e27-e37. doi: 10.1016/S2352-3026(23)00314-9. Epub 2023 Nov 16.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
96 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apixaban and No systemic anticoagulant prophylaxis in people with Lymphoma and Acute Lymphoblastic Leukemia, run by Bristol-Myers Squibb at 96 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 96 sites in United States, Belgium, Canada, Russia, Australia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants With Non-Fatal DVT, PE, and CVST, and VTE-Related-Death (time frame: From first dose up to approximately 40 days after first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02369653, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.