Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia (AML) in Elderly Patients
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Other: Best Supportive Care
- Registration Number
- NCT05188326
- Lead Sponsor
- Associazione Qol-one
- 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 remission (CR) following conventional induction ('3+7') and consolidation chemotherapy.
- 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 following conventional induction ('3+7') and consolidation chemotherapy to evaluate 2 an 5 year post-remission rates of Overall Survival and disease free survival between two arms
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Azacitidine Vidaza 100 milligram (mg) injection Vidaza consists of 50 mg/ m2 s.c or i.v for 7 days (5 + weekend off + 2) every 28 days and increase after 1st cycle, if well tolerated, to 75 mg/m2 s.c or i.v. for 7 days (5 + weekend off + 2) every 28 days for further 5 cycles followed by cycles every 56 days for 4 years and six months Best supportive care Best Supportive Care No drug administration
- Primary Outcome Measures
Name Time Method Disease free Survival (DFS) 5 years Disease-free survival (DFS) at 2 and 5 years. Events for DFS are death and first relapse (either AML or myelodysplastic syndrome (MDS) recurrence) and death; observations are censored at the date of last contact if alive and disease-free. DFS will be calculated from the date of achievement of CR to the date of 1st relapse or death. Patients still alive in 1st CR will be censored at the moment of last visit/contact.
- Secondary Outcome Measures
Name Time Method Hospitalizations 5 years Number and length of hospitalizations in the post-remission period.
Overall Survival (OS) 2 and 5 years Overall survival (OS) at 2 and 5 years. Event for OS in both arms is death and patients are censored at the date of last contact if alive
Trial Locations
- Locations (18)
A.O. SS. Antonio e Biagio e Cesare Arrigo
🇮🇹Alessandria, AL, Italy
Ospedale Riuniti
🇮🇹Ancona, AN, Italy
A.O. S. Giovanni Moscati
🇮🇹Avellino, AV, Italy
Policlinico Università di Bari
🇮🇹Bari, BA, Italy
Ospedale L'Annunziata
🇮🇹Cosenza, CS, Italy
Ospedale Ferrarotto
🇮🇹Catania, CT, Italy
Ospedale Garibaldi
🇮🇹Catania, CT, Italy
Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, FG, Italy
Università degli Studi di Genova
🇮🇹Genova, GE, Italy
IRCCS Ospedale Maggiore Policlinico
🇮🇹Milano, MI, Italy
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