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

Acute Myeloid Leukemia Clinical Trial

Official title:

A Randomized Study to Evaluate the Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05188326
• Other study ID #: QOLESS-AZA-AMLE
• Status: Completed
• Phase: Phase 3
• Start date: November 28, 2010
• Est. completion date: September 27, 2021

Study information

• Verified date: June 2023
• Source: Associazione Qol-one
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 27, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 61 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Vidaza 100 milligram (mg) injection
1st cycle 50 mg/sqm s.c. or i.v. for 7 days (5 + weekend off + 2) every 28 days and increase dosing after 1st cycle, if well tolerated, to 75 mg/ m2 for further 5 cycles, followed by cycles every 56 days for 4 years and six months post-remission.

Other:
• Best Supportive Care
Best supportive care includes antibiotics, transfusions and fluids

Locations

Country	Name	City	State
Italy	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 Ferrarotto	Catania	CT
Italy	Ospedale Garibaldi	Catania	CT
Italy	Ospedale L'Annunziata	Cosenza	CS
Italy	Università degli Studi di Genova	Genova	GE
Italy	IRCCS Ospedale Maggiore Policlinico	Milano	MI
Italy	Ospedale Civile Spirito Santo	Pescara	PE
Italy	Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli	Reggio Calabria	RC
Italy	Ospedale Sant'Eugenio	Roma	RM
Italy	Policlinico Agostino Gemelli	Roma	RM
Italy	Azienda Ospedaliera Sant'Andrea	Rome	RM
Italy	IRCCS Istituto Regina Elena	Rome	RM
Italy	A.O.U. San Giovanni di Dio e Ruggì D'Aragona	Salerno	SA
Italy	Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo	FG
Italy	A.O.U. di Udine Centro Trapianti e Terapie Cellulari	Udine

Sponsors (1)

Lead Sponsor	Collaborator
Associazione Qol-one

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free Survival (DFS)	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.	5 years
Secondary	Hospitalizations	Number and length of hospitalizations in the post-remission period.	5 years
Secondary	Overall Survival (OS)	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	2 and 5 years