Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia (AML) in Elderly Patients

Phase 3

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Vidaza 100 milligram (mg) injection; 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

Study Timeline

• Study Start: 2010-11-28
• Primary Completion: 2021-09-27
• Study Completion: 2021-09-27
• Study First Submitted: 2021-12-27
• Study First Submitted QC: 2021-12-27
• Study First Posted: 2022-01-12
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

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

A.O. S. Giovanni Moscati; 🇮🇹 Avellino, AV, Italy

Policlinico Università di Bari; 🇮🇹 Bari, BA, Italy

Ospedale L'Annunziata; 🇮🇹 Cosenza, CS, Italy

Ospedale Garibaldi; 🇮🇹 Catania, CT, Italy

IRCCS Ospedale Maggiore Policlinico; 🇮🇹 Milano, MI, Italy

Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli; 🇮🇹 Reggio Calabria, RC, Italy

Ospedale Ferrarotto; 🇮🇹 Catania, CT, Italy

Università degli Studi di Genova; 🇮🇹 Genova, GE, Italy

Ospedale Civile Spirito Santo; 🇮🇹 Pescara, PE, Italy

Ospedale Sant'Eugenio; 🇮🇹 Roma, RM, Italy

Policlinico Agostino Gemelli; 🇮🇹 Roma, RM, Italy

Azienda Ospedaliera Sant'Andrea; 🇮🇹 Rome, RM, Italy

A.O.U. di Udine Centro Trapianti e Terapie Cellulari; 🇮🇹 Udine, Italy

IRCCS Istituto Regina Elena; 🇮🇹 Rome, RM, Italy

Ospedale Riuniti; 🇮🇹 Ancona, AN, Italy

Ospedale Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni Rotondo, FG, Italy

A.O.U. San Giovanni di Dio e Ruggì D'Aragona; 🇮🇹 Salerno, SA, Italy