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

NCT ID: NCT05188326

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-28
• Study Completion Date: 2021-09-27

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

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Azacitidine

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

Group Type: EXPERIMENTAL

Vidaza 100 milligram (mg) injection

Intervention Type: DRUG

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.

Best supportive care

No drug administration

Group Type: PLACEBO_COMPARATOR

Best Supportive Care

Intervention Type: OTHER

Best supportive care includes antibiotics, transfusions and fluids

Interventions

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.

Intervention Type: DRUG

Best Supportive Care

Best supportive care includes antibiotics, transfusions and fluids

Intervention Type: OTHER

Other Intervention Names

Vidaza

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.

• Minimum Eligible Age: 61 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Associazione Qol-one

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esther Natalie Oliva

Role: STUDY_CHAIR

QOL-ONE Associazione Culturale e di Ricerca

Locations

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

Milan, 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

A.O.U. di Udine Centro Trapianti e Terapie Cellulari

Udine, , Italy

Countries

Italy

Other Identifiers

QOLESS-AZA-AMLE

Identifier Type: -

Identifier Source: org_study_id