Randomized maintenance therapy with Azacitidine (Vidaza) in older patients (>= 60 years of age) with acute myeloid leukemia (AML) and refractory anemia with excess of blasts (RAEB, RAEB-t)

Phase 3

Completed

• Conditions: Acute myeloid leukemia; leukemia; 10024324

• Registration Number: NL-OMON37945
• Lead Sponsor: HOVO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 86

Inclusion Criteria

- Age 60 years or more
- Subjects with a cytopathologically confirmed diagnosis of
(a) AML (M0-M2 and M4-M7, FAB classification)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.
- Less than 5% bone marrow blasts and absence of Auer rods after 2 cycles of induction therapy
- Hematological recovery, i.e. ANC >= 0.5 x 109/l and platelets >= 50 x 109/l
- WHO performance status <= 2
- Written informed consent

Exclusion Criteria

- Extramedullary disease
- Planned allogeneic hematopoietic cell transplantation
- Previous polycythaemia rubra vera
- Primary myelofibrosis
- Blast crisis of chronic myeloid leukemia
- AML-FAB type M3 or AML with cytogenetic abnormality t(15;17)
- Impaired hepatic or renal function as defined by:
ALT and/or AST > 2.5 x normal value
Bilirubin > 2 x normal value
Serum creatinin > 2 x normal value (after adequate hydration)
- Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.)
- Cardiac dysfunction as defined by:
Myocardial infarction within the last 6 months of study entry, or
Reduced left ventricular function with an ejection fraction <50%
Unstable angina
Unstable cardiac arrhythmias

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Disease-free survival measured from the date of randomization to relapse or<br /><br>death from any cause whichever comes first. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Overall survival measured from the date of randomization<br /><br>- Probability of relapse and death after inclusion from date of randomization<br /><br>calculated as competing risks.<br /><br>- Number and duration of hospitalization as well as transfusion requirements<br /><br>(red cell and platelet transfusion).<br /><br>- Adverse events </p><br>