A Phase I Trial of Volasertib (BI 6727), an Intravenous Polo-Like Kinase Inhibitor, in Combination With 7+3 Induction Chemotherapy for Patients With Acute Myeloid Leukemia
The study intervention involved in this study is the addition of a dose of volasertib as a part of the initial chemotherapy regimen for AML. The trial will involve a combination of the following drugs: * Volasertib (the study drug) * Idarubicin * Cytarabine
• Participants must have pathologically confirmed, newly diagnosed acute myeloid leukemia.
• Adults, age 18 years or older at the time of diagnosis, eligible for standard induction chemotherapy according to their treating physician.
• ECOG performance status 0-2 (Karnofsky ≥60%, see Appendix A)
• Left ventricular ejection fraction \> 50% as measured by echocardiogram or MUGA scan
• Must not have received systemic antineoplastic therapy including radiation therapy within 14 days of the study enrollment, except hydroxyurea or 6-mercaptopurine for the purposes of cytoreduction as per the treating physician. Patients may also have received all-trans retinoic acid (ATRA) if there is an early suspicion of acute promyelocytic leukemia (APL, M3-AML), although if confirmed to have APL these patients will be excluded from the study.
• Female patients of childbearing age must have negative pregnancy test.
• Participants must have normal organ and marrow function as defined below:
‣ total bilirubin \< 3 times the ULN
⁃ creatinine within normal institutional limits OR
⁃ creatinine clearance ≥30 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
• The effects of volasertib (BI 6727) on the developing human fetus are unknown. For this reason and because other chemotherapeutic agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and 6 months after completion of therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation, and 6 months after completion of therapy.
• Ability to understand and the willingness to sign a written informed consent document.