EUCTR2005-002258-23-IT
Active, not recruiting
Not Applicable
A Randomized, Open-Label Study of Oral CEP-701 Administered in Sequence With Standard Chemotherapy to Patients With Relapsed Acute Myeloid Leukemia (AML) Expressing FLT-3 Activating Mutations
CEPHALON EUROPE0 sites220 target enrollmentNovember 4, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Myeloid Leukemia
- Sponsor
- CEPHALON EUROPE
- Enrollment
- 220
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •?Cytological confirmation of AML ?Relapsed disease following first CR of duration 1 \- 24 months Time from first relapse to study entry £ 30 days ?Confirmation of FLT 3 positive status after point of initial relapse ?Aged ³ 18 years and older ?Written informed consent ?Ability to understand and comply with study restrictions ?No co\-morbid conditions that would limit life expectancy to \<3 months ?ECOG 0 \- 2 ?Pregnancy precautions as appropriate
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •?Bilirubin \>2 times ULN, ALT or AST \>3 times ULN ?Serum creatinine \>1\.5 mg/dL ?Resting ejection fraction \<45% (MEC patients only) ?Untreated or progressive infection ?Physical or psychiatric condition that may compromise participation ?Known central nervous system involvement with AML ?Any prior treatment with a FLT 3 inhibitor ?Requirement for HIV protease inhibitors ?Active gastrointestinal ulceration or bleeding ?Use an investigational drug that is not expected to be cleared by the start of CEP\-701
Outcomes
Primary Outcomes
Not specified
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