Palbociclib in Combination With Chemotherapy in Pediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (RELPALL2)
Trial Parameters
Brief Summary
With this research study has following goals * To confirm the highest tolerable dose of palbociclib in combination with chemotherapy is safe and well-tolerated. * To learn more about side effects of palbociclib in combination with chemotherapy; * To learn more about the biological effects of palbociclib on the cells in your body
Eligibility Criteria
Inclusion Criteria: 1. Participants must have a diagnosis of acute lymphoblastic leukemia and disease meets at least one of the following criteria: 1. relapsed or refractory to chemotherapy as defined by ≥ 5% leukemic blasts in the bone marrow or flow cytometry confirmed leukemic blasts in the peripheral blood 2. relapsed after hematopoietic stem cell transplantation (HSCT) 3. Subjects must have had histologic, morphologic or flow cytometric verification of the malignancy at relapse 2. Prior Treatment: 1. Subjects who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study. 2. Subjects who relapse on therapy other than standard ALL maintenance must have fully recovered from the acute toxic effects of all prior anti cancer therapy, defined as resolution of all such toxicities to ≤ Grade 2 or lower per the inclusion/exclusion criteria prior to entering this study. 3. At least 14 days must have elapsed since