- HOVON 67 AML SAKK
- Active sites:
Reduced intensity chemotherapy given with and without Imatinib Mesylate in patients >= 60 years considered unfit for standard chemotherapy with previously untreated Acute Myeloid Leukemia (AML) and refractory anemia with excess of Blasts (RAEB, RAEB-t).
- Prospective randomized Phase II study
- Monitoring Type:
- Inclusion Criteria:
- Patients >= 60 years.
- Patients considered unfit for standard chemotherapy.
- Patients with a confirmed diagnosis of
a. AML FAB M0-M2 or M4�M7 (see appendix A) or
b. with refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-T) with an IPSS score > 1.5
- Subjects with secondary AML progressing from antecedent (at least 4 months duration) myelodysplasia are also eligible.
- AST (SGOT) and ALT (SGPT), total serum bilirubin, serum creatinine, and creatinine clearance not more than 1.5 x the upper limit of the normal range (ULN) at the laboratory where the analyses were performed.
- Male patients agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following the discontinuation of study drug.
- Written informed consent.
- Exclusion Criteria:
- Patients previously treated for AML (any antileukemic therapy including investigational agents)
- Patients with cardiac dysfunction as defined by:
a. Myocardial infarction within the last 6 months prior to study entry
b. Reduced left ventricular ejection fraction of < 50% as evaluated by echocardiogram or MUGA scan
c. Unstable angina
d. Unstable cardiac arrhythmia
- Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable
- Patients with any serious concomitant medical condition, which could, in the opinion of the investigator, compromise participation in the study.
- Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.