AML except FAB M3 or t(15
Conditions
Interventions
Patients will be randomized between either maintenance therapy with Azacitidine or observation. Patients will receive maintenance treatment until relapse, for a maximum of 12 cycles.
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 7041560
Fax: 010 7041028
e-mail: hdc@erasmusmc.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 60 years or more; 2. Subjects with a cytopathologically confirmed diagnosis of: A. AML (M0-M2 and M4-M7, FAB classification); B. Refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-t) with an IPSS score of >=1.5. 3. Less than 5% bone marrow blasts and absence of Auer rods after 2 cycles of induction therapy (this induction therapy can be according to HOVON81, HOVON92 or similar protocols); 4. Hematological recovery, i.e. ANC >= 0.5 x 109/l and platelets >= 50 x 109/l; 5. WHO performance status <= 2; 6. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Extramedullary disease; 2. Planned allogeneic hematopoietic cell transplantation; 3. Previous polycythaemia rubra vera; 4. Primary myelofibrosis; 5. Blast crisis of chronic myeloid leukemia; 6. AML-FAB type M3 or AML with cytogenetic abnormality t(15;17); 7. Impaired hepatic or renal function as defined by: A. ALT and/or AST > 2.5 x normal value; B. Bilirubin > 2 x normal value; C. Serum creatinin > 2 x normal value (after adequate hydration). 8. Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.); 9. Cardiac dysfunction as defined by: A. Myocardial infarction within the last 6 months of study entry; B. Reduced left ventricular function with an ejection fraction <50% as measured by MUGA scan or echocardiogram; C. Unstable angina.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival measured from the date of randomization to relapse or death from any cause whichever comes first. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival measured from the date of randomization; 2. Probability of relapse and death after inclusion from date of randomization calculated as competing risks; 3. Number and duration of hospitalization as well as transfusion requirements (red cell and platelet transfusion); 4. Adverse events. | — |
Contacts
Public ContactG. Huls
Postbus 30001
Outcome results
None listed