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 Pegylated (PEG) L-Asparaginase

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 15-001971
    NCT ID: NCT02369653
    Sponsor Protocol Number: ACCL1333/CV185155

About this study

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 Pegylated L-Asparaginase and have a central line (a catheter inserted for administration of medications and blood sampling).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • New diagnosis of de novo ALL, lymphomas (T or B cell), or mixed-phenotype acute leukemia
  • Planned induction chemotherapy with a corticosteroid, vincristine and a single dose or multiple doses of PEG L-asparaginase, with or without daunorubicin consistent with the Children's Oncology Group (COG) ALL trials
  • 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.
  • Platelet Counts ≥ 20000/microL

Exclusion Criteria:

  • Subjects scheduled to have > 3 Lumbar Punctures over the course of the 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Vilmarie Rodriguez, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20151356

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