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Title:
ACCL1333/CV185155: A Phase III Randomized, Open Label, Multi-center Study on 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
Protocol Number:
PIACCL1333
Phase:
Phase III
Physician:
Patrick Brown
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
The purpose of this study (the “main study”) is to see if adding the investigational study drug apixaban will decrease the chance of having a blood clot during planned chemotherapy treatment.Patients getting chemotherapy that includes L-asparaginase have a risk of developing blood clots that can complicate their treatment. There is no standard way to try to prevent these clots. Apixaban (ELIQUIS) is approved by the Food and Drug Administration (FDA) to reduce the risk of stroke and blood clots in adults who have atrial fibrillation. This research study will try to see if using Apixaban during the first cycle of chemotherapy will lower the chance of developing a blood clot.
Eligibility:
Subjects eligible for the study include both males and females, age 1 to less than 18 years with newly diagnosed ALL or newly diagnosed lymphomas (T or B cell) and a new cenral venous access device inserted within 4 days prior to Day 1 of induction chemotherapy or up to Day 4 of induction chemotherapy.
Treatment:
There is a 50% chance that an enrolled subject will receive the study drug apixaban. If the subject does not receive the study drug apixaban, he or she will receive usual care by the study doctor. Apixaban will be taken by mouth (in tablet or liquid form) or by feeding tube (in liquid form) two times a day, once in the morning and once in the evening, for 25-28 days while you are undergoing induction chemotherapy. Apixaban administration must be discontinued at least 24 hours prior to any planned lumbar puncture and resumed no sooner than 18-24 hours after the procedure. On Day 29 of when the induction chemotherapy starts, subjects will receive an ultrasound of both arms to see if he or she has any clots in their veins and an echocardiogram to see if there are any clots around the central venous catheter.
Population:
Pediatric
Last Update
03/05/2019 05:03 AM