Clinical trial NCT05188326: Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia (AML) in Elderly Patients
Official title: A Randomized Study to Evaluate the Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia,
Post-Remission Therapy
Lead sponsor: Associazione Qol-one
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 54
Sex: ALL
Minimum age (years): 61
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. Age 61 years or more
2. Newly diagnosed AML with \> 30% myeloid marrow blasts, either "de novo" or evolving from a MDS not previously treated with chemotherapeutic agents.
3. Absence of central nervous system involvement
4. No contraindications for intensive chemotherapy, defined as:

   1. prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;
   2. a creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;
   3. a Performance Status (PS) score of \> 2;
   4. uncontrolled severe infection.
5. Informed consent.

Exclusion Criteria:

1. Age ≤ 60 years
2. Newly diagnosed AML with \< 30% myeloid marrow blasts
3. Previously treated AML
4. Central nervous system involvement
5. Prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;
6. A creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;
7. A PS score of \> 2;
8. Uncontrolled severe infection.

Primary outcomes:
measure: Disease free Survival (DFS)
timeFrame: 5 years
Secondary outcomes:
measure: Hospitalizations
timeFrame: 5 years
measure: Overall Survival (OS)
timeFrame: 2 and 5 years
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: A.O. SS. Antonio e Biagio e Cesare Arrigo
state: AL
city: Ancona
country: Italy
facility: Ospedale Riuniti
state: AN
city: Avellino
country: Italy
facility: A.O. S. Giovanni Moscati
state: AV
city: Bari
country: Italy
facility: Policlinico Università di Bari
state: BA
city: Cosenza
country: Italy
facility: Ospedale L'Annunziata
state: CS
city: Catania
country: Italy
facility: Ospedale Ferrarotto
state: CT
city: Catania
country: Italy
facility: Ospedale Garibaldi
state: CT
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza
state: FG
city: Genova
country: Italy
facility: Università degli Studi di Genova
state: GE
city: Milano
country: Italy
facility: IRCCS Ospedale Maggiore Policlinico
state: MI
city: Pescara
country: Italy
facility: Ospedale Civile Spirito Santo
state: PE
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
state: RC
city: Roma
country: Italy
facility: Ospedale Sant'Eugenio
state: RM
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli
state: RM
city: Rome
country: Italy
facility: Azienda Ospedaliera Sant'Andrea
state: RM
city: Rome
country: Italy
facility: IRCCS Istituto Regina Elena
state: RM
city: Salerno
country: Italy
facility: A.O.U. San Giovanni di Dio e Ruggì D'Aragona
state: SA
city: Udine
country: Italy
facility: A.O.U. di Udine Centro Trapianti e Terapie Cellulari
Study officials:
affiliation: QOL-ONE Associazione Culturale e di Ricerca
name: Esther Natalie Oliva
role: STUDY_CHAIR
References: