Status:
COMPLETED
Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia (AML) in Elderly Patients
Lead Sponsor:
Associazione Qol-one
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
61+ years
Phase:
PHASE3
Brief Summary
The present study aims to compare the efficacy of postremission maintenance therapy with 5-Aza versus best supportive care (BSC) in a cohort of AML patients aged \>60 years, who have achieved complete...
Detailed Description
The present study aims to compare the efficacy of postremission maintenance therapy with 5-Aza versus best supportive care (BSC) in a cohort of AML patients aged \>60 years, who have achieved CR follo...
Eligibility Criteria
Inclusion
- Age 61 years or more
- Newly diagnosed AML with \> 30% myeloid marrow blasts, either "de novo" or evolving from a MDS not previously treated with chemotherapeutic agents.
- Absence of central nervous system involvement
- No contraindications for intensive chemotherapy, defined as:
- prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;
- a creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;
- a Performance Status (PS) score of \> 2;
- uncontrolled severe infection.
- Informed consent.
Exclusion
- Age ≤ 60 years
- Newly diagnosed AML with \< 30% myeloid marrow blasts
- Previously treated AML
- Central nervous system involvement
- Prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;
- A creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;
- A PS score of \> 2;
- Uncontrolled severe infection.
Key Trial Info
Start Date :
November 28 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2021
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05188326
Start Date
November 28 2010
End Date
September 27 2021
Last Update
June 8 2023
Active Locations (18)
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1
A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, AL, Italy
2
Ospedale Riuniti
Ancona, AN, Italy
3
A.O. S. Giovanni Moscati
Avellino, AV, Italy
4
Policlinico Università di Bari
Bari, BA, Italy