Status:
COMPLETED
Liposomal Cytarabine-Daunorubicin CPX-351 in Treating Patients With Untreated Myelodysplastic Syndrome or Acute Myeloid Leukemia
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acute Biphenotypic Leukemia
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This randomized clinical trial studies liposomal cytarabine-daunorubicin CPX-351 in treating patients with untreated myelodysplastic syndrome or acute myeloid leukemia. Drugs used in chemotherapy, suc...
Detailed Description
PRIMARY OBJECTIVES: I. Estimate whether the 32 units/m\^2 or the 64 units/m\^2 or both dose levels of CPX-351 (liposomal cytarabine-daunorubicin CPX-351) are likely to improve treatment-related morta...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 7 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2017
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01804101
Start Date
May 7 2013
End Date
January 10 2017
Last Update
May 25 2018
Active Locations (2)
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1
Stanford Cancer Institute
Palo Alto, California, United States, 94304
2
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109