Safety Study of CPX-351 in Children With Relapsed Leukemia or Lymphoma
Status:
Completed
Trial end date:
2019-04-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to test the safety of a study drug called CPX-351. This drug has
been tested in adults but not yet in children and adolescents. This study tests different
doses of the drug to see which dose is safer in children and adolescents.
Patients who have blood cancer are being asked to take part in this study . Blood cancers may
include leukemia and lymphoma. Patients able to be in this study have already been treated
with standard chemotherapy for their disease and the disease is still growing or has come
back.
CPX-351 is a drug that is not yet approved by the United States Food and Drug Administration
(FDA) and is only used in research studies like this one. CPX-351 is made up of two
chemotherapy drugs that patients may have already received called cytarabine and daunorubicin
that are now packaged together.
Another purpose of this study is to collect blood samples for special research studies.
Researchers want to study how much of the CPX-351 is in the body over time. These studies are
call pharmacokinetic studies or PK studies for short. PK studies require the collection of
several blood samples before and after participants are given the study drug.