| Inclusion Criteria: | 1) Patients who have a diagnosis of acute myeloid leukemia that is relapsed or refractory to at least 1 prior treatment for leukemia, or patients with chronic myeloid leukemia (CML) who are in myeloid blast crisis which have failed at least 1 previous tyrosine kinase inhibitor (TKI). A baseline bone marrow assessment is required </= 96 hours prior to the first dose of study drug. The results of this bone marrow assessment do not need to be known prior to the first dose of study drug.
2) Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
3) Must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, cancer related hormone therapy, or other investigational therapy for at least 21 days for myelosuppressive agents (such as cytarabine, daunorubicin, and gemtuzumab ozogamicin) or 14 days for non-myelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (such as neurotoxicity, diarrhea, and mucositis) . . .
4) . . . except for residual myelosuppression and alopecia. Hydroxyurea is permitted to control the peripheral blast cell count, but must be stopped at least 24 hours before study drug administration.
5) Have given written informed consent approved by Lilly and the ethical review board (ERB)/institutional review board (IRB) governing the site.
6) Female patients of child-bearing potential must have a negative serum pregnancy test within 96 hours of enrollment. Male and female patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
7) Exhibit patient compliance and geographic proximity that allow for adequate follow-up.
8) Patient must be at least 18 years of age.
9) Have adequate organ function including: Hepatic: Bilirubin <=1.5 x ULN. Alkaline phosphatase and transaminases (ALT and AST) <= 5 x ULN. However, ALT and/or AST elevations > 5 x ULN may be acceptable with asymptomatic or clinically nonrelevant elevation of these isolated transaminases. For example, elevation of transaminases may be secondary to heart or muscle disease (elevation of AST) or inflammatory reactions affecting the liver (elevation of ALT) that is not indicative of severe hepatic impairment or hepatic metastases. (continued)
10) In addition, combined AST and ALT without increases in bilirubin may be observed in patients experiencing hemolysis. In cases where elevations of AST, ALT, and/or bilirubin are noted at baseline, the patient may enter treatment as long as there is evidence that the laboratory elevations of the liver-related enzymes are not a reflection of severe hepatic impairment. Renal: Serum creatinine <= ULN. No known active renal disease. In rare cases, patients may enter treatment with a serum creatinine > ULN as elevations of serum creatinine may be secondary to dehydration. (continued)
11) This requires prior approval by the Lilly physician and must be consistent with the patient's history. |