Treatment With Combination Chemotherapy for Relapsed or Refractory Acute Lymphoblastic Leukemia
Status:
Terminated
Trial end date:
2020-07-29
Target enrollment:
Participant gender:
Summary
Leukemia cells grow and divide fast and out of control. In normal cells, certain proteins
called CDK4 and CDK6 control cell growth. The study drug called palbociclib works by blocking
the CDK4 and CDK6 proteins. Palbociclib has been shown to kill leukemia cells in the
laboratory and in animal studies. Palbociclib will be added to other chemotherapy drugs, such
as dexamethasone, that are known to be effective in treating childhood ALL.
This study will be done in two parts: Part 1: Dose Escalation and Part 2: Dose Expansion. The
goal of Part 1 of the study is to find the highest tolerable combination of palbociclib and
chemotherapy that the investigators can give to patients with leukemia. Once those doses are
determined, the investigators will enroll patients on Part 2: Dose Expansion. This phase will
enroll additional patients that receive the highest tolerated dose of palbociclib as
determined in part 1, in order to better understand the side effects and how effective this
treatment approach is.
With this research study, the investigators hope to meet the following goals:
- To find the highest tolerable dose of palbociclib in combination with chemotherapy that
can be given without causing severe side effects;
- To learn what kind of side effects palbociclib in combination with chemotherapy may
have; and
- To learn more about the biology effects of palbociclib on the cells in the participant's
body.
Up to 40 children, adolescents and young adults will participate in both parts of this study
at St. Jude only.