A Single-arm, Open Label, Multi-center Phase I/II Trial to Assess the Safety and Efficacy of BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML Unfit for an Intensive Induction Therapy
Inclusion Criteria:
- Patients with newly diagnosed AML (except APL) according to the FAB or WHO
classification, including AML evolving from MDS or other hematological diseases and
AML after previous cytotoxic therapy or radiation (secondary AML), with medical
contraindications against or not willing to receive a standard induction and
consolidation therapy.
- Bone marrow aspirate or biopsy must contain > 20% blasts of all nucleated cells. In
AML FAB M6 ≥ 30% of non-erythroid cells in the bone marrow must be leukemic blasts.
In patients with 20-30% blasts, the indication for a treatment with hypomethylating
agents (5-azacitidine or decitabine) should be considered prior to inclusion into the
trial.
- Age ≥ 60 years
- Informed consent, personally signed and dated to participate in the study
- Male patients enrolled in this trial must use adequate barrier birth control measures
during the course of treatment and for at least 3 months after the last
administration of study therapy (low-dose cytarabine and/or BIBF 1120).
Exclusion Criteria:
- Patients with 20-30% bone marrow blasts which are qualifying for and consenting into
a therapy with hypomethylating agents
- Patients who are eligible for and consenting into a standard chemotherapy
- Known central nervous system manifestation of AML
- Inadequate liver function (ALT and AST ≥ 2.5 x ULN) if not caused by leukemic
infiltration
- Known chronically active hepatitis C infection or acute hepatitis
- Chronically impaired renal function (creatinin clearance < 30 ml/min)
- Uncontrolled hypertension with a resting pressure systolic > 160 mmHg or diastolic >
95 mmHg despite adequate treatment
- severe trauma or surgery within 4 weeks of study entry
- severe, non-healing wounds, ulcer or fracture
- Uncontrolled active infection
- Concurrent malignancies other than AML or other severe diseases which in the opinion
of the investigator are likely to influence the endpoint assessment
- Hypersensitivity to cytarabine (not including drug fever or exanthema)
- Previous treatment of AML except hydroxyurea up to 24 hours before study medication
- Previous therapy with tyrosine kinase inhibitors or angiogenesis inhibitors
- Parallel participation in another clinical trial for the same indication. Eligibility
of patients with investigational drug therapy outside of this trial during or within
4 weeks of study entry should be discussed with the study office prior to study entry
- Any severe concomitant condition, which makes it undesirable for the patient to
participate in the study or which could jeopardize compliance with the protocol