EUCTR2005-002258-23-DE
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 - NA
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Relapsed Acute Myeloid Leukaemia (AML) expressing FLT-3 activating mutations.
- Sponsor
- Cephalon Inc.
- Enrollment
- 220
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients are included in the study if all of the following criteria are met at the baseline visit:
- •cytological confirmation of AML
- •relapsed disease following first CR of a duration of 1 month (30 days) to 24 months (730 days). The time from first relapse to study entry (start of first course of induction chemotherapy) must be no longer than 30 days.
- •confirmation of FLT 3 activating mutation positive status after point of initial relapse
- •aged 18 years and older
- •written informed consent
- •ability to understand and comply with study restrictions
- •no comorbid conditions that would limit life expectancy to less than 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2
- •women must be neither pregnant nor lactating, and either of nonchildbearing potential or using adequate contraception with a negative pregnancy test at study entry
Exclusion Criteria
- •Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- •bilirubin levels greater than 2 times upper limit of normal (ULN), alanine transaminase or aspartate transaminase levels greater than 3 times ULN
- •serum creatinine concentrations greater than 1\.5 mg/dL
- •resting ejection fraction of left ventricle less than 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 central nervous system involvement with AML
- •any previous treatment with a FLT 3 inhibitor
- •patient requires current treatment for the human immunodeficiency virus (HIV) with protease inhibitors
- •active gastrointestinal ulceration or bleeding
Outcomes
Primary Outcomes
Not specified
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