Relapsed Acute Myeloid Leukaemia (AML) expressing FLT-3 activating mutations.
Conditions
Interventions
Product Name: Lestaurtinib
Product Code: CEP-701
Pharmaceutical Form: Oral solution
INN or Proposed INN: Lestaurinib
CAS Number: 111358-88-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentra
Sponsors
Cephalon Inc.
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: 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
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 • use of an investigational drug within 30 days of the baseline visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective 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) at the outcome assessment.;Secondary Objective: The secondary objectives of the study are to determine the following: • the proportion of patients who achieve an outcome of CR with incomplete blood count recovery (CRi) • the proportion of patients who achieve an outcome of partial remission (PR) • the proportion of patients who maintain an outcome of CR up to day 113 • the proportion of patients who crossover to sequential CEP 701 treatment who achieve an outcome of CR at day 113 • remission duration (for patients who achieve a CR) • event-free survival • overall survival • safety and tolerability of CEP 701 administered in sequence with chemotherapy throughout the study • pharmacokinetics of CEP 701 at specified time points • CEP 701 inhibitory activity in plasma by means of a FLT 3 (fms-like tyrosine kinase 3) exvivo bioassay and cell assay at specified time points ;Primary end point(s): The proportion of patients who achieve an outcome of complete remission at the outcome assessment. The secondary variables are as follows: • the proportion of patients who achieve an outcome of CRi or PR • the proportion of patients who maintain an outcome of CR up to day 113 • the proportion of patients who achieve an outcome of CR at day 113 who crossover to sequential treatment with CEP 701 • remission duration (for patients who achieve a CR) • event-free survival for all patients • overall survival for all patients | — |
Countries
Germany, Italy, Spain, Sweden
Outcome results
None listed