Description:

Study of CEP-701 in Patients With Acute Myeloid Leukemia (AML) See http://clinicaltrials.gov/ct2/show/study/NCT00079482

Link:

http://clinicaltrials.gov/ct2/show/study/NCT00079482

Keywords:
Versions (2) ▾
  1. 11/18/11
  2. 3/26/14
Uploaded on:

March 26, 2014

DOI:
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License:
Creative Commons BY 4.0
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Eligibility NCT00079482 AML

Eligibility AML NCT00079482

  1. StudyEvent: Eligibility
    1. Eligibility AML NCT00079482
Inclusion criteria
cytological confirmation of AML
relapsed disease following first CR of 1 month(30days) to 24 months(730days). The time from first relapse to study entry (start of first course of induction chemotherapy) must be no longer than 30days
confirmation of FLT-3 activating mutation positive status after point of initial relapse
aged 18 years or older
no comorbid conditions that would limit life expectancy to less than 3 months
ECOG Performance Score of 0, 1,or 2
women must be neither pregnant nor lactating, and either of non-childbearing potential or using adequate contraception with a negative pregnancy test at study entry
Exclusion criteria
bilirubin > 2x ULN
ALT/AST > 3x ULN
serum creatinine > 1.5 mg/dL
resting ejection fraction of left ventricle < 45% (applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine (MEC))
untreated or progressive infection
any physical or psychiatric condition that may compromise participation in the study
known CNS involvement with AML
any previous treatment with a FLT-3 inhibitor
requires current treatment for HIV with protease inhibitors
active GI ulceration or bleeding
use of an investigational drug that is not expected to be cleared by the start of CEP-701 treatment