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- AML003 (ARMADA 2000): Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of CPI-613® (devimistat) in Combination with High Dose Cytarabine and Mitoxantrone (CHAM) Compared to High Dose Cytarabine and Mitoxantrone (HAM) therapy and control sub-groups: combination of Mitoxantrone, Etoposide and Cytarabine (MEC) and combination of Fludarabine, Cytarabine, and Filgrastim (FLAG) in Older Patients (? 50 years) with Relapsed/Refractory Acute Myeloid Leukemia (AML)
Clinical Trial
AML003 (ARMADA 2000): Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of CPI-613® (devimistat) in Combination with High Dose Cytarabine and Mitoxantrone (CHAM) Compared to High Dose Cytarabine and Mitoxantrone (HAM) therapy and control sub-groups: combination of Mitoxantrone, Etoposide and Cytarabine (MEC) and combination of Fludarabine, Cytarabine, and Filgrastim (FLAG) in Older Patients (? 50 years) with Relapsed/Refractory Acute Myeloid Leukemia (AML)
This study is being conducted because new medications are needed for the treatment of patients with Acute Myeloid Leukemia (AML) and involves giving patients an investigational drug called CPI-613 (devimistat). CPI-613 works by blocking the creation of the energy that cancer cells need to survive, grow in your body and make more cancer cells.
Eligibility Criteria
- Male or female, aged 18 years or older Subjects with confirmed Acute Myeloid Leukemia (AML) Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures Must not be receiving any other investigational product
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