Liposomal Cytarabine-Daunorubicin CPX-351 in Treating Patients With Untreated Myelodysplastic Syndrome or Acute Myeloid Leukemia

Not Recruiting

Trial ID: NCT01804101

Purpose

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, 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.

Official 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

Eligibility


Inclusion Criteria:

   - 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 Criteria:

   - 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

Intervention(s):

other: Laboratory Biomarker Analysis

drug: Liposomal Cytarabine-Daunorubicin CPX-351

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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