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); A randomized phase II study.
Completed
- Conditions
- AM
- Registration Number
- NL-OMON25417
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1. Patients >= 60 years;
2. Patients considered unfit for standard chemotherapy;
Exclusion Criteria
1. Patients previously treated for AML (any antileukemic therapy including investigational agents);
2. Patients with cardiac dysfunction as defined by:
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CR rate.
- Secondary Outcome Measures
Name Time Method 1. Overall survival (time from registration till the death of the patient.);<br /><br>2. Event free survival (i.e., time from registration to induction failure, death or disease progression, whichever occurs first);<br /><br>3. Adverse events / toxicity.