Main info

Identificatie:

HOVON 67 AML SAKK

Sponsor:

HOVON

Included patients:

6

Active sites:

9

(of 9)

Title:

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).

Timeline

Flow

Details

Phase:

Prospective randomized Phase II study

Monitoring Type:

Objectives:

Eligibility

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.

Participating Sites

= Active hospitals

= Inactive hospitals