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Leukemia

Liposomal Cytarabine-Daunorubicin CPX-351 for Untreated Myelodysplastic Syndrome or Acute Myeloid Leukemia (2642)
Liposomal Cytarabine and Daunorubicin (CPX-351) for Adults With Untreated High-Risk MDS and Non-APL AML at High Risk of Treatment-Related Mortality
Status Conditions Phase Study ID
Recruiting Acute Myeloid Leukemia
Myelodysplastic Syndrome
N/A 2642
NCT01804101
Summary

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 or by stopping them from dividing


Investigator
Roland B. Walter, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Diagnosis of untreated "high-risk" MDS (>= 10% blasts) or AML other than 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
  • TRM score >= 13.1 as calculated with simplified model
  • Bilirubin < 2.0 mg/mL x upper limit of normal
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 4.0 x upper limit of normal
  • Left ventricular ejection fraction (LVEF) >= 40%, assessed within 28 days prior to registration, e.g. by multi gated acquisition scan (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
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
Last Updated
May 28, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • 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.