Palbociclib and Sorafenib, Decitabine, or Dexamethasone in Treating Patients With Recurrent or Refractory Leukemia

• Status: Recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial studies the side effects and best dose of palbociclib when given alone and in combination with sorafenib, decitabine, or dexamethasone in treating patients with leukemia that has come back (recurrent) or that does not respond to previous treatment (refractory). Palbociclib, sorafenib, and decitabine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib alone and in combination with sorafenib, decitabine, or dexamethasone may work better in treating patients with recurrent or refractory leukemia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); Pfizer
• Treatments: Azacitidine; BB 1101; Decitabine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ichthammol; Niacinamide; Palbociclib; Sorafenib

Criteria

Inclusion Criteria:

• Patients with a diagnosis of histologically confirmed relapsed or refractory (R/R) acute myeloid leukemia or R/R acute lymphoblastic leukemia for which no available standard therapies are indicated or anticipated to result in a durable response

• Only patients with R/R ALL will be eligible for cohort C

• Patients must not have had leukemia therapy for 14 days prior to starting palbociclib. However, patients with rapidly proliferative disease may receive hydroxyurea as needed until 24 hours prior to starting therapy on this protocol and during the first cycle of study

• Bilirubin =< 2 mg/dL

• Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN) or =< 5 x ULN if related to leukemic involvement

• Creatinine =< 1.5 x ULN

• Known cardiac ejection fraction of > or = 45% within the past 3 months

• Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

• A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial

• Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol

Exclusion Criteria:

• Pregnant women are excluded from this study because the agent used in this study has the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided

• Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Patient with documented hypersensitivity to any of the components of the therapy program

• Patients with active, uncontrolled central nervous system (CNS) leukemia will not be eligible

• Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation

• Patients with known history of serous retinopathy will not be eligible

• Prior treatment with palbociclib