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Liposomal Cytarabine and Daunorubicin (CPX-351) for Adults with Untreated High-Risk MDS and Non-APL AML at High Risk of Treatment-Related Mortality

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
    
Phase       Pilot

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Research Study Description

This clinical trial studies liposomal cytarabine-daunorubicin CPX-351 in treating patients with untreated myelodysplastic syndrome or acute myeloid leukemia. Drugs used in chemotherapy, such as liposomal cytarabine-daunorubicin CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

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)

- Refractory/relapsing blast crisis of chronic myelogenous leukemia (CML)

- 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.



Research Study Number       2642.00
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
   

Keywords
Acute Myeloid Leukemia (AML); Hematologic Malignancies; Leukemia

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  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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