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).

Recruiting

• Conditions: AML except FAB M3 or t(15; 17), and RAEB or RAEB-t with IPSS >= 1.5, age >= 60 yrs.

• Registration Number: NL-OMON20498
• Lead Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data Center Erasmus MC - Daniel den Hoed Postbus 5201 3008 AE RotterdamTel: 010 7041560 Fax: 010 7041028 e-mail: hdc@erasmusmc.nl

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 126

Inclusion Criteria

1. Age 60 years or more;

2. Subjects with a cytopathologically confirmed diagnosis of:

Exclusion Criteria

1. Extramedullary disease;

2. Planned allogeneic hematopoietic cell transplantation;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Overall survival measured from the date of randomization;<br /><br>2. Probability of relapse and death after inclusion from date of randomization calculated as competing risks;<br /><br>3. Number and duration of hospitalization as well as transfusion requirements (red cell and platelet transfusion);<br /><br>4. Adverse events.