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Complete title: Mitoxantrone, Etoposide, and Cytarabine (MEC) Following Epigenetic Priming with Decitabine in Adults with Relapsed/Refractory Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS): A Phase I/II Study
|Research Study Number||2652.00|
|Principal Investigator||Roland Walter, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Prior diagnosis of "high-risk" myelodysplastic syndrome (MDS) (= or> 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
- Relapsed/persistent disease according to standard criteria requiring salvage therapy; outside diagnostic material is acceptable as long as peripheral blood and/or bone marrow slides are reviewed at the study institution; flow cytometric analysis of peripheral blood and/or bone marrow should be performed according to institutional practice guidelines
- Patients with prior autologous or allogeneic hematopoietic cell transplantation (HCT) are eligible if relapse occurs > 180 days post-transplant provided symptoms of graft-versus host disease are well controlled with stable use of immunosuppressive agents
- Treatment-related mortality (TRM) score = or < 9.2 as calculated with simplified model
- Should be off any active therapy for AML with the exception of hydroxyurea for at least 14 days prior to study registration unless patient has rapidly progressive disease, and all grade 2-4 non-hematologic toxicities should have resolved
- May have previously received monotherapy with demethylating agents for MDS or AML
- May have previously received chemotherapy with MEC for MDS or AML
- Patients with symptoms/signs of hyperleukocytosis or white blood cells (WBC) > 100,000/µL can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg/m^2/dose) prior to enrollment
- Bilirubin = or < 2 x institutional upper limit of normal (IULN) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert's syndrome, or hemolysis (assessed within 7 days prior to registration)
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum pyruvate glutamate transaminase (SPGT) (alanine aminotransferase [ALT]) = or < 2 x IULN unless elevation is thought to be due to hepatic infiltration by AML (assessed within 7 days prior to registration)
- Serum creatinine = or < 1.5 x IULN (assessed within 7 days prior to registration)
- Left ventricular ejection fraction = or > 40%, assessed within 28 days prior to registration, e.g. by multigated acquisition (MUGA) scan or echocardiography, or other appropriate diagnostic modality and no clinical evidence of congestive heart failure; if the patient had anthracycline-based therapy since the most recent cardiac assessment, cardiac evaluation should be repeated if there is clinical or radiographical suspicion of cardiac dysfunction, or if the previous cardiac assessment was abnormal
- Women of childbearing potential and men must agree to use adequate contraception
- Provide 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
- Known hypersensitivity to any study drug
- Pregnancy or lactation
- Patients may not be receiving any other investigational agents
Other exclusion criteria may apply.
Acute Myeloid Leukemia (AML); Hematologic Malignancies; Leukemia
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