Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)

Inclusion Criteria

• Patients with recurrent or refractory B- or T-lineage lymphoblastic leukemia and lymphoma.
• Patients with leukemia must have ≥ 5% (M2 or M3) bone marrow blasts with or without an extramedullary site of relapse. Morphologic relapse for M2 should be confirmed using flow cytometry, FISH and/or cytogenetics or molecular techniques.
• Patients with LL must have either measurable or evaluable disease.
• Patients with first or greater relapsed T-lineage ALL or LL and second or greater relapsed B-lineage ALL or LL are eligible.
• Patients with primary refractory disease with at least 2 prior induction attempts or first relapse refractory to at least one prior re-induction attempt are eligible.
• Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients 72 hours prior does not count as protocol therapy.
• Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or ANC counts): >= 7 days after the last dose of agent. See DVL homepage for commercial and Phase 1 investigational agent classifications. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned Research Coordinator prior to enrollment.
• NOTE: Cytoreduction with prednisone or methylprednisolone for = 21 days must have elapsed from infusion of last dose of antibody with the exception of blinatumomab, and toxicity related to prior antibody therapy must be recovered to Grade = 14 days must have elapsed since last dose of corticosteroid and toxicity related to prior immune therapy must be recovered to Grade = 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair and the study-assigned Research Coordinator.
• Interleukins, Interferons and Cytokines (other than Hematopoietic Growth Factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than Hematopoietic Growth Factors)
• Stem cell Infusions (with or without TBI):
• Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including DLI or boost infusion: >= 84 days after infusion and no evidence of GVHD.
• Autologous stem cell infusion including boost infusion: >= 42 days.
• Cellular Therapy: >= 30 days after the completion of any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells, etc.)
• XRT/External Beam Irradiation including Protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial BM radiation.
• Patients must not have received prior exposure to palbociclib or another CDK4/6 inhibitor.
• Adequate Renal Function Defined as:
• Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 or
• A serum creatinine based on age/gender as follows:
• Age: 1 to = 16 years; Male: 1.7 mg/dL; Female: 1.4 mg/dL
• Adequate Liver Function Defined as:
• bilirubin (sum of conjugated + unconjugated) = 2 g/dL.
• Adequate Cardiac Function Defined As:
• Shortening fraction of >= 27% by echocardiogram, or
• Ejection fraction of >= 50% by gated radionuclide study.
• All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

Exclusion Criteria

• Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies. Based on the mechanism of action, palbociclib may be expected to cause fetal harm if used during pregnancy. Pregnancy tests must be obtained in girls who are post-menarche. Males or fe