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HOVON 135

Originele protocol

Inclusion criteria

  • Patients with:
    • a diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML, or
    • acute leukemia’s of ambiguous lineage according to WHO 2008 or
    • a diagnosis of refractory anemia with excess of blasts (MDS) and IPSS-R > 4.5
  • Patients 66 years and older.
  • Patients NOT eligible for standard chemotherapy, defined as HCT-CI ≥ 3. (Appendix G) or Patient NOT eligible for standard chemotherapy for other reasons (wish of patient).
  • WBC ≤ 30 x109/L (prior hydroxyurea allowed for a maximum of 5 days, stop 2 days before start decitabine treatment)
  • Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:
    • Serum creatinine ≤ 2.5 mg/dL (≤ 221.7 μmol/L), unless considered AML-related
    • Serum bilirubin ≤ 2.5 x upper limit of normal (ULN), unless considered AML-related or due to Gilbert’s syndrome
    • Alanine transaminase (ALT) ≤ 2.5 x ULN, unless considered AML-related
  • WHO performance status 0, 1 or 2
  • Male patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
  • Written informed consent.
  • Patient is capable of giving informed consent.

Exclusion criteria

  • Acute promyelocytic leukemia.
  • Patients previously treated for AML (any antileukemic therapy including investigational agents), a short treatment period ( ≤ 5 days) with Hydroxyurea is allowed
  • Diagnosis of any previous or concomitant malignancy is an exclusion criterion: except when the patient completed successfully treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 6 months prior to randomization.
  • Blast crisis of chronic myeloid leukemia.
  • Inability to discontinue any anti-coagulants (including ascal)
  • Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etc.)
  • Cardiac dysfunction as defined by:
    • Myocardial infarction within the last 3 months of study entry, or
    • Reduced left ventricular function with an ejection fraction < 40% as measured by MUGA scan or echocardiogram or
    • Unstable angina or
    • New York Heart Association (NYHA) grade IV congestive heart failure (see Appendix I) or
    • Unstable cardiac arrhythmias
  • Patient has had major surgery within the past 4 weeks or a major wound that has not fully healed.
  • Vaccinated with live, attenuated vaccines within 4 weeks prior to randomization.
  • History of stroke or intracranial hemorrhage within 6 months prior to randomization.
  • Patient has a history of human immunodeficiency virus (HIV) or active infection with Hepatitis C or B.
  • Patient has symptomatic central nervous system (CNS) leukemia (NO routinely lumbar puncture required to investigate CNS involvement)
  • Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance.
  • Patients with any serious concomitant medical condition which could, in the opinion of the investigator, compromise participation in the study.
  • Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.
  • Current concomitant chemotherapy, radiation therapy, or immunotherapy; other than hydroxyurea
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule