Last updated on February 2018

Comparison Between Two Dose Levels of Daunorubicin and Between One vs. Two Induction Cycles for Adult Patients With AML

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute myeloid leukemia
  • Age: Between 18 - 65 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Newly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria, i.e. bone marrow aspirate or biopsy must contain 20% blasts of all nucleated cells or differential blood count must contain 20% blasts. In acute erythroid leukemia, 20% blasts in all non-erythroid bone marrow cells. In AML defined by cytogenetic aberrations, the rate of blasts may be <20%. Secondary AMLs are eligible for inclusion.
  • Age 18- inkl.65 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
  • Total bilirubin 1.5 times the upper limit of normal
  • alanine transaminase (ALT) and aspartate transaminase (AST) 2.5 times upper limit of normal
  • Creatinine 1.5 times upper limit of normalExclusion Criteria:
  • Adequate cardiac function, i.e. left ventricular ejection fraction (LVEF) of 50% as assessed by transthoracic two-dimensional echocardiography ("M Mode") or multiple gated acquisition scan (MUGA scan)
  • Signed informed consent
  • Women must fulfill at least one of the following criteria in order to be eligible for trial inclusion:
  • Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with Serum follicle stimulating hormone (FSH) > 40 U/ml)
  • Postoperative (i.e. 6 weeks) after bilateral ovariectomy with or without hysterectomy
  • Continuous and correct application of a contraception method with a Pearl Index of <1% (e.g. implants, depots, oral contraceptives, intrauterine device - IUD).
  • Sexual abstinence
  • Vasectomy of the sexual partner

Exclusion criteria:

  • Patients who are not eligible for standard chemotherapy as assessed by the treating physician
  • Central nervous system manifestation of AML
  • Cardiac disease: i.e. heart failure New York Heart Association (NYHA) III or IV; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • Patients undergoing renal dialysis
  • Chronic pulmonary disease with clinical relevant hypoxia
  • Known HIV or Hepatitis infection
  • Uncontrolled active infection
  • Medical conditions other than AML with an estimated life expectancy below 6 months
  • Previous treatment of AML except hydroxyurea up to 5 days
  • Relapsed or primary refractory AML
  • Acute promyelocytic leukemia
  • Previous anthracycline-containing chemotherapy
  • Treatment with any known non-marketed drug substance or experimental therapy within 4 weeks prior to enrollment
  • Incapability of understanding purpose and possible consequences of the trial
  • Pregnant or breastfeeding women
  • Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lacking compliance)

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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