Why are we doing this research?
The purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of palbociclib administered in combination with re-induction chemotherapy in pediatric patients with relapsed B- or T-lineage ALL/LL. Also to define and describe the toxicities of palbociclib administered on this schedule and to characterize the pharmacokinetics of palbociclib in pediatric patients with relapsed B- or T-lineage ALL/LL.
AINV18P1: A Phase 1 study of Palbociclib (IND#141416). A CDK 4/6 Inhibitor, in combination with chemotherapy in children with relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)