Palbociclib and Dexamethasone in Treating Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

PRIMARY OBJECTIVES:

I. To determine the dose and schedule of the combination of palbociclib and dexamethasone in
patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia (ALL).

ii. To determine the safety and tolerability of the combination of palbociclib and
dexamethasone in patients with relapsed or refractory adult B-cell ALL.

SECONDARY OBJECTIVES:

I. To evaluate the activity of palbociclib in combination with dexamethasone in patients with
relapsed or refractory B-cell ALL.

Inclusion Criteria:

- Patients must have histologic evidence of relapsed or refractory B-cell ALL

- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
2 or less

- Philadelphia chromosome positive (Ph+) patients must be refractory to or intolerant of
standard tyrosine kinase inhibitor therapy

- Patients must be able to consume oral medication

- Patients must have recovered to =< grade 1 or stabilized from the toxic effects of any
prior chemotherapy (except alopecia)

- Creatinine clearance (CrCL) >= 60 mL/min/1.73 m^2 calculated by Cockcroft-Gault

- Total bilirubin < 1.5 x upper limit of normal (ULN)

- Negative serum or urine pregnancy test for women with child-bearing potential

- Patients must be able to sign consent and be willing and able to comply with scheduled
visits, treatment plan, procedures, and laboratory testing

Exclusion Criteria:

- Patients must not have evidence of active central nervous system (CNS) disease

- Patients must not be receiving any chemotherapy agents (except hydroxyurea);
intrathecal methotrexate and intrathecal cytarabine are permissible

- Patients must not be receiving growth factors (granulocyte colony-stimulating factor
[G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF]), except for
erythropoietin

- Patient must not have a concurrent active malignancy for which they are receiving
treatment.

- Patients with other severe concurrent disease which in the judgment of the
investigator would make the patient inappropriate for entry into this study are
ineligible

- Patients must not have received any investigational agents within 30 days of study
entry unless they have exceeded 5 terminal half-lives of the previous study drug used
for treatment

- Patients must not be pregnant or breastfeeding; pregnancy tests must be obtained for
all females of child-bearing potential within 10 days prior to enrollment; males or
women of childbearing potential may not participate unless they have agreed to use an
effective contraceptive method (defined as hormonal contraceptives, intrauterine
devices, surgical contraceptives, or condoms)

- Patients who have uncontrolled infection are not eligible; patients must have any
active infections under control; fungal disease must have been adequately treated for
at least 2 weeks before study entry; subjects with bacteremia must have documented
negative blood cultures prior to study entry

- Patients who are candidates for allogeneic transplantation, have a suitable donor, and
are willing to undergo transplantation

- Patients who are eligible for and willing to receive treatment with blinatumomab,
inotuzumab ozogamizin, or tisagenlecleucel.