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Complete title: Liposomal Cytarabine and Daunorubicin (CPX-351) for Adults with Untreated High-Risk MDS and Non-APL AML at High Risk of Treatment-Related Mortality
|Research Study Number||2642.00|
|Principal Investigator||Roland Walter, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Diagnosis of untreated "high-risk" MDS (>= 10% blasts) or AML other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 2008 World Health Organization (WHO) classification; patients with biphenotypic AML are eligible; outside diagnostic material is acceptable as long as peripheral blood and/or bone marrow slides are reviewed at the study institution and cytogenetic/molecular information is available
- * Prior hydroxyurea for AML is permitted but should be discontinued prior to start of CPX-351 treatment
- * Azacitidine, decitabine, lenalidomide, and growth factors are permitted for low-risk MDS (< 10% blasts); all treatments for MDS should be discontinued prior to start of CPX-351 treatment
- Treatment-related mortality (TRM) score >= 13.1 as calculated with simplified model
- Bilirubin < 2.0 mg/mL x upper limit of normal; this requirement reflects the excretion of CPX-351 by the liver
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 4.0 x upper limit of normal; this requirement reflects the excretion of CPX-351 by the liver
- Left ventricular ejection fraction (LVEF) >= 40%, assessed within 28 days prior to registration, e.g. by multi gated acquisition (MUGA) scan or echocardiography, or other appropriate diagnostic modality
- Patients with symptoms/signs of hyperleukocytosis or white blood cell (WBC) > 100,000/uL can be treated with leukapheresis prior to enrollment
- Provide signed written informed consent
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Concomitant illness associated with a likely survival of < 1 year
- Active systemic fungal, bacterial, viral, or other infection, unless under treatment with anti-microbials and controlled/stable, as defined as being afebrile and hemodynamically stable for 24-48 hours
Other exclusion criteria may apply.
Leukemia, Acute Myeloid (AML); Hematologic Malignancies; Leukemia
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