Male or female patients older than 60 years of age with confirmed AML (except for APL) according to the WHO definition who relapsed after or are refractory to prior chemotherapy. Leukocyte count should be = 25,000 /µl (25 x 109/Liter). Patient should be not eligible for intensive treatment options. Patient should have a life expectancy = 2 months and Eastern co-operative oncology group performance score of 2 or less.
Conditions
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients older than 60 years of age • Patient with confirmed AML (except for APL) according to the WHO definition who relapsed after or are refractory to prior chemotherapy • Leukocyte count = 25,000 /µl (25 x 109/Liter) • Patient not eligible for intensive treatment options • Life expectancy = 2 months • Eastern co-operative oncology group performance score of 2 or less • Signed written informed consent consistent with international conference on harmonisation – good clinical practice (ICH-GCP) and local legislation 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: • Patient with acute promyelocytic leukaemia (APL, AML of the French-American-British (FAB) classification subtype M3) • Hypersensitivity to the trial drug or the excipients • Secondary malignancy requiring therapy • Known central nervous system involvement • Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal, or AST or ALT greater than 5 times the upper limit of normal in case of known liver involvement • Bilirubin greater than 1.5 mg/dl (> 26 umol/l, SI unit equivalent) • Serum creatinine greater than 2.0 mg/dl • Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia • Psychiatric illness or social situation that would limit compliance with trial requirements • Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug (see also section 4.2.2) • Chemotherapy (except hydroxyurea, see section 4.2.2) or immunotherapy within the past two weeks prior to treatment with BI 2536 • Any other investigational drugs within a period of the drug's half-life x5 prior to treatment with BI 2536 • Persistence of toxicities of prior anti-leukaemia therapies which are deemed to be clinically relevant • Patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermacide, etc.) • Patient unable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The present trial will be performed to determine the MTD and to evaluate the efficacy of BI 2536 in the treatment of elderly patients with relapsed or refractory AML. A single dose of 200 mg BI 2536 administered on day one of a treatment course will be compared with 50 mg BI 2536 administered on days one, two and three of a treatment course to identify the better dosing schedule for the further development programme of BI 2536. After implementation of protocol amendment 3 an additional treatment schedule with administration of BI 2536 on days one and eight of a three-week treatment course will be investigated. With implementation of protocol amendment 3 the dosing schedule with BI 2536 administered on days one, two and three will be discontinued. However, patients that were randomized into the day one, two and three schedule before implementation of protocol amendment 3 will continue treatment according to the schedule in repeated cycles as long as they are eligible.;Secondary Objective: Further analysis of efficacy parameters, including event free survival, overall survival, and remission duration. Pharmakokinetic analysis, safety analysis (incidence and intensity of adverse events, incidence of DLT), and pharmacodynamic monitoring of drug effect on leukaemia cells (assays for polyploidy and G2/M arrest) will be performed.;Primary end point(s): 1.) Maximum tolerated dose 2.) Best objective response (complete remission, CR; complete remission with incomplete blood count recovery, CRi; partial remission, PR) | — |
Countries
Austria, Germany
Outcome results
None listed