Acute myeloid leukemia MedDRA version: 16.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Vidaza
Product Name: Vidaza
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: AZACITIDINE
CAS Number: 320-67-2
Other descriptive name: Vidaza
Concentration unit:
Sponsors
HOVON Foundation
Eligibility
Sex/Gender
All
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, appendix A), or (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 Note: Subjects with a secondary AML progressing from antecedent myelodysplasia and biphenotypic leukaemia are eligible. 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. Of note: also patients who are treated according to one of these protocols but were not formally included in these studies are eligible for HOVON97) 4) Hematological recovery, i.e. ANC ³ 0.5 x 109/l and platelets ³ 50 x 109/l 5) WHO performance status =65 years) yes F.1.3.1 Number of subjects for this age range 100
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, or b) Reduced left ventricular function with an ejection fraction <50% c) Unstable angina d) Unstable cardiac arrhythmias
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess, in a randomized study the value of Azacitidine as post remission therapy (in comparison to observation) in elderly patients with AML, RAEB or RAEB-t with respect to the disease free survival.;Secondary Objective: Post remission Azacitidine therapy will be evaluated with respect to toxicity, probability of relapse and probability of death in first CR and overall survival. To evaluate prognostic factors (e.g. phenotype, cytogenetics) in the context of post remission therapy with Azacitidine as regards to overall survival, and disease free survival. ;Primary end point(s): Disease-free survival measured from the date of randomization to relapse or death from any cause whichever comes first.;Timepoint(s) of evaluation of this end point: The final analysis of the primary endpoints will be done one year after last patient has gone off protocol treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Overall survival measured from the date of randomization •Probability of relapse and death after inclusion from date of randomization calculated as competing risks. •Number and duration of hospitalization as well as transfusion requirements (red cell and platelet transfusion). •Adverse events (according to Appendix E);Timepoint(s) of evaluation of this end point: The final analysis of the primary endpoints will be done one year after last patient has gone off protocol treatment. | — |
Countries
Belgium, Netherlands
Contacts
Public ContactHOVON Data Center
Erasmus MC, Clinical Trial Center
Outcome results
None listed