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), refractory anemia with excess blasts in transformation (RAEB-T): a randomized phase II study

Completed

• Conditions: Acute myeloid leukemia (AML); Cancer; Leukemia

• Registration Number: ISRCTN70542454
• Lead Sponsor: Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-07
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients >/= 60 years
2. Patients considered unfit for standard chemotherapy
3. Patients with a confirmed diagnosis of
a. Acute myeloid leukemia (M0-M2 and M4-M7, FAB classification)
b. With refractory anemia with excess of blasts (RAEB) or refractory anemia with
excess of blasts in transformation (RAEB-T) with an International Prognostic Scoring System (IPSS) score >/= 1.5
4. Subjects with secondary AML progressing from antecedent (at least 4 months duration) myelodysplasia are also eligible
5. Serum glutamic-oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT), total serum bilirubin, serum creatinine, and creatinine clearance not more than 1.5 x the upper limit of normal (ULN) at the laboratory where the analyses were performed
6. Male patients agree to employ an effective barrier method of birth control throughout the study and for up to three months following the discontinuation of study drug
7. Written informed consent

Exclusion Criteria

1. Patients previously treated for AML (any antileukemic therapy including investigational agents)
2. Patients with cardiac dysfunction as defined by:
a. Myocardial infarction within the last six months prior to study entry
b. Reduced left ventricular ejection fraction of <50% as evaluated by echocardiogram or multiple-gated acquisition left ventricular (MUGA) scan
c. Unstable angina
d. Unstable cardiac arrhythmia
3. Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable
4. Patients with any serious concomitant medical condition, which could, in the opinion of the investigator, compromise participation in the study
5. Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified