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Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Conditions: Recurrent B Acute Lymphoblastic Leukemia, Refractory B Acute Lymphoblastic Leukemia
Interventions: Palbociclib, Dexamethasone
Countries: United States
This phase I trial studies the side effects and best dose of palbociclib when given together with dexamethasone in treating participants with B-cell acute lymphoblastic leukemia that has come back after a period of improvement or does not respond to treatment. Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Dexamethasone is a steroid medication that is used in combination with other medications to treat B-cell acute lymphoblastic leukemia. Giving palbociclib together with dexamethasone may work better in treating patients with B-cell acute lymphoblastic leukemia.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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 tisagenlecleucel.
- Philadelphia, Pennsylvania, United States