Description:

ODM derived from http://clinicaltrials.gov/show/NCT00701766

Link:

http://clinicaltrials.gov/show/NCT00701766

Keywords:
Versions (3) ▾
  1. 12/9/13
  2. 4/16/14
  3. 4/16/14
Uploaded on:

April 16, 2014

DOI:
No DOI assigned. To request one pleaselog in.
License:
Creative Commons BY-NC 3.0 Legacy
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Eligibility DRKS00003838 NCT00701766 Leukemia, Myeloid, Acute

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Older than 60 years
Patient with confirmed AML (except for APL) according to the WHO definition who relapsed after or are refractory to prior chemotherapy
White Blood Cell Count procedure (WBC)
Patient not eligible for intensive treatment options
Life expectancy >= 2 months
ECOG performance status finding <= 2
Signed written informed consent consistent with international conference on harmonisation - good clinical practice (ICH-GCP) and local legislation
Exclusion Criteria
Patient with acute promyelocytic leukaemia (APL, AML of the French-American-British (FAB) classification subtype M3)
Hypersensitivity to the trial drug or the excipients
Secondary malignancy requiring therapy
Central nervous system (CNS) involvement status
Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal, or AST or ALT > 5 times the upper limit of normal in case of known liver involvement
Bilirubin > 1.5 mg/dl (> 26 mcmol/l, SI unit equivalent)
Serum Creatinine Measurement
Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia
Psychiatric illness or social situation that would limit compliance with trial requirements
Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug
Chemotherapy (except hydroxyurea) or immunotherapy or treatment with any other investigational drug within the past four weeks prior to treatment with the trial drug
Persistence of toxicities of prior anti-leukaemia therapies which are deemed to be clinically relevant
Patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermicide, etc.)
Patient unable to comply with the protocol