Description:

ODM derived from http://clinicaltrials.gov/show/NCT00632749

Link:

http://clinicaltrials.gov/show/NCT00632749

Keywords:
Versions (2) ▾
  1. 12/9/13
  2. 4/15/14
Uploaded on:

April 15, 2014

DOI:
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License:
Creative Commons BY 4.0
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Eligibility DRKS00003742 NCT00632749 Leukemia, Myeloid, Acute

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age at least 18 Years
Male or female adult with previously untreated acute myeloid leukaemia (AML)
Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL)
Patient is considered ineligible for intensive treatment
Patient is eligible for low-dose cytarabine (LD-Ara-C) treatment
Life expectancy > 3 months
Eastern co-operative oncology group (ECOG, R01-0787) performance score <=2 at screening
Signed written informed consent consistent with international conference on harmonisation good clinical practice (ICH-GCP) and local legislation
Exclusion Criteria
Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification).
Relapsed or treatment refractory AML.
Hypersensitivity to one of the trial drugs or the excipients.
Other malignancy requiring treatment.
Known central nervous system involvement.
Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal (ULN).
INR > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin).
Bilirubin
Serum Creatinine Measurement
LVEF (Left ventricular ejection fraction) < 50% in echocardiography or clinical congestive heart failure New York Heart Association (NYHA) grade III or IV.
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 (i.e. other chemo- or immunotherapy, see also section 4.2.2).
Contraindications for cytarabine treatment according to the summary of product characteristics (SPC).
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.).
Pregnant or nursing female patients.
Patient unable to comply with the protocol.