Uproleselan, Cladribine, and Low Dose Cytarabine for the Treatment of Patients With Treated Secondary Acute Myeloid Leukemia

Korábbi kezelés

• Pregnant women are excluded from this study because the agents used in this study have 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.
• 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.
• Prior treatment with uproleselan.

Más betegség

• Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with documented hypersensitivity to any of the components of the chemotherapy program.

Egyéb

• Patients with a diagnosis of acute promyelocytic leukemia (AML-M3) will be excluded from this study.

• Patients with a diagnosis of treated secondary-AML (TS-AML) who have not received therapy for their AML will be eligible.
• TS-AML is defined as AML arising from a previously treated antecedent myeloid neoplasm (myelodysplastic syndrome or myeloproliferative neoplasm that has been previously treated with hypomethylating agents).
• Patients must be at least 7 days from their last therapy for the antecedent myeloid neoplasm
• Age \>/= 18 years.
• Adequate organ function as defined below:
  • liver function (total bilirubin \< 2mg/dL, AST and/or ALT \<3 x ULN - or \<5 x ULN if related to leukemic involvement)
  • kidney function (creatinine \< 1.5 x ULN ).
  • known cardiac ejection fraction of \> or = 45% within the past 6 months
• ECOG performance status of ≤ 2.
• A negative urine or serum 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 informed consent. A signed informed consent by the patient is required prior to their enrollment on the protocol.