AML
Conditions
Interventions
The reduced intensity chemotherapy will consist of one induction cycle (cycle I) followed by one cycle of consolidation (cycle II).
The chemotherapy regimen for induction is as follows:
-Ara-C 100
-Daunorubicin (DNR) 45 mg/m2/day iv 3h, days 1-2
The chemotherapy regimen for consolidation is as follows:
-Ara-C 100 mg/m2/day iv continuous infusion, days 1-5
Patients assigned to the imatinib arm, in addition will receive a daily dose of 600 mg imatinib p.o. from day 1 of the chemotherapy cycle till the end of week 40 (or until disease progression (death),
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 4391568
Fax: 010 4391028
e-mail: hdc@erasmusmc.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients >= 60 years; 2. Patients considered unfit for standard chemotherapy; 3. Patients with a confirmed diagnosis of: a. AML FAB M0-M2 or M4–M7 (see appendix A); 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; 4. Subjects with secondary AML progressing from antecedent (at least 4 months duration) myelodysplasia are also eligible; 5. 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; 6. 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; 7. Written informed consent.
Exclusion criteria
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 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; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival (time from registration till the death of the patient.); 2. Event free survival (i.e., time from registration to induction failure, death or disease progression, whichever occurs first); 3. Adverse events / toxicity. | — |
Contacts
Public ContactB. Löwenberg
Erasmus Medical Center, Daniel den Hoed Cancer Center, Department of Hematology, P.O. Box 5201
Outcome results
None listed