Acute Myeloid Leukemia
Conditions
Keywords
AML
Brief summary
The purpose of the study is to determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML) who achieve a second complete remission (CR).
Detailed description
Patients randomly assigned to chemotherapy alone received the second course of induction chemotherapy as soon as clinically indicated; patients randomly assigned to receive chemotherapy plus sequential lestaurtinib had lestaurtinib withheld for 3 days (72 hours) before the start of the second 5-day course of chemotherapy and resumed lestaurtinib treatment 2 days (48 hours) after the final administration of the second course of chemotherapy.
Interventions
DRUGCEP-701
Chemotherapy
DRUGMitozantrone, Etoposide, Cytarabine (combination Chemotherapy)
Chemotherapy
Sponsors
Cephalon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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; * written informed consent; * ability to understand and comply with study restrictions; * 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 l \< 45%(applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine \[MEC\]; * untreated or progressive infection; * any physical or psychiatric cdtn 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed AML who achieve a second complete remission or a complete remission with incomplete platelet count recovery. | 113 days |
Secondary
| Measure | Time frame |
|---|---|
| - overall survival - event-free survival - remission duration - safety and tolerability of CEP-701 - pharmacokinetics of CEP-701 - CEP-701 inhibitory activity | 113 days |
Countries
Australia, Canada, Germany, Israel, Italy, New Zealand, Poland, Romania, Russia, Spain, Sweden, Ukraine, United States
Outcome results
None listed