Safety and Effectiveness Study of CPI-613 to Treat Refractory or Relapsed Leukemia and Myelodysplastic Syndrome

Inclusion Criteria

• •Have either documented refractory or relapsed AML, or documented MDS of any risk group that has failed a hypomethylating agent (such as decitabine \[Vidaza\] and azacitidine \[AZA\]). (Therapy failure with a hypomethylating agent is defined as patients who have been sufficiently treated with hypomethylating agents without response in the opinion of the treating physician, or whose disease has progressed or relapsed while on a hypomethylating agent.) Has never been treated with CPI-613.
• •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• •Expected survival \>2 months.
• •18 years of age and older of both genders.
• •Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive, or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
• •Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists.
• •No radiotherapy, surgery or hormonal therapy for any kind of within 2 weeks prior to participating in this study. Patients must have fully recovered from the acute toxicities of any prior treatment with any anti-cancer drugs (including hypomethylating agents in MDS patients), radiotherapy or other anti-cancer modalities (i.e., returned to baseline status as noted before most recent treatment) for any tumors. Patients with persisting, stable chronic toxicities from such prior treatment ≤Grade 1 are eligible, but must be documented as such.
• •Recombinant erythropoietin or G-CSF is not allowed, since CPI-613 does not induce myelosuppression.
• •No evidence of active or serious infection of any kind within the past month. No systemic fungal, bacterial, viral or other infection not controlled, defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment.
• •Signed informed consent form.