A Pilot Study of Allopurinol As A Modifier of 6-MP Metabolism in Pediatric ALL
Status:
Completed
Trial end date:
2020-04-06
Target enrollment:
Participant gender:
Summary
This research is being done to determine if allopurinol can change the metabolism of the oral
chemotherapeutic medication 6-mercaptopurine (6-MP) in children with acute lymphoblastic
leukemia (ALL). 6-MP is originally started at a standard dose in children with ALL, but the
dose is adjusted according to the absolute neutrophil count (ANC). Occasionally, 6-MP doses
need to be increased in order to get the ANC into a specific target range. Also, increasing
the 6-MP dose can lead to unwanted side effects, such as inflammation of the liver as shown
by increases in laboratory values (ALT, aspartate aminotransferase (AST), bilirubin), nausea,
and abdominal discomfort. Previous studies in children with inflammatory bowel disease has
shown that combining allopurinol with 6-MP can decrease side effects associated with high
doses of 6-MP and also increase the efficacy of 6-MP. Allopurinol is approved by the Food and
Drug Administration for the treatment of tumor lysis syndrome in ALL. Through this research
study, the investigators hope to show that the combination of allopurinol and 6-MP will be
safe, tolerable, and effective in children with ALL.
Phase:
Early Phase 1
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins