BI 811283 in Combination With Cytarabine in Previously Untreated AML Ineligible for Intensive Treatment
Condition: Leukemia, Myeloid, Acute
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: BI 811283 (d 1 and 15); Cytarabine; BI 811283 (d1); Cytarabine
Intervention description: BI 811283 (24 hours i.v.c.i.) on day 1 and 15 of a 4-week treatment cycle; Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle; BI 811283 (24 hours i.v.c.i.) on day 1 of a 4-week treatment cycle; Cytarabine 2 x 20 mg/d s.c. on days 1-10 of a 4-week treatment cycle
Intervention MeSH terms: Cytarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Investigation of maximum tolerated dose, safety, efficacy and pharmcokinetics of BI 811283 in
      combination with cytarabine (LD-Ara-C) in previously untreated acute myeloid leukaemia (AML)
      patients
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female adult with previously untreated acute myeloid leukaemia (AML)

          -  Confirmed diagnosis of AML according to the WHO definition (except for acute
             promyelocytic leukaemia, APL)

          -  Patient is considered ineligible for intensive treatment

          -  Patient is eligible for low-dose cytarabine (LD-Ara-C) treatment

          -  Life expectancy > 3 months

          -  Eastern co-operative oncology group (ECOG, R01-0787) performance score <=2 at
             screening

          -  Signed written informed consent consistent with international conference on
             harmonisation good clinical practice (ICH-GCP) and local legislation

        Exclusion criteria:

          -  Patient with APL (AML subtype M3 according to the French-American-British (FAB)
             classification).

          -  Relapsed or treatment refractory AML.

          -  Hypersensitivity to one of the trial drugs or the excipients.

          -  Other malignancy requiring treatment.

          -  Known central nervous system involvement.

          -  Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5
             times the upper limit of normal (ULN).

          -  INR > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon,
             warfarin).

          -  Bilirubin greater than 1.5 mg/dl.

          -  Serum creatinine greater than 2.0 mg/dl.

          -  LVEF (Left ventricular ejection fraction) < 50% in echocardiography or clinical
             congestive heart failure New York Heart Association (NYHA) grade III or IV.

          -  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 (i.e. other chemo- or immunotherapy, see also section
             4.2.2).

          -  Contraindications for cytarabine treatment according to the summary of product
             characteristics (SPC).

          -  Patients who are sexually active and unwilling to use a medically acceptable method of
             contraception during the trial (hormonal contraception, intrauterine device, condom
             with spermicide, etc.).

          -  Pregnant or nursing female patients.

          -  Patient unable to comply with the protocol.