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

Associazione Qol-one54 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia

Interventions

Vidaza 100 milligram (mg) injectionDRUG

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 CareOTHER

Best supportive care includes antibiotics, transfusions and fluids

Eligibility

Sex: ALLMin age: 61 Years

Medical Language ↔ Plain English

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.

Locations (18)

A.O. SS. Antonio e Biagio e Cesare Arrigo

Alessandria, AL, Italy

Ospedale Riuniti

Ancona, AN, Italy

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Secondary Outcomes

Hospitalizations

Number and length of hospitalizations in the post-remission period.

Time frame: 5 years

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

Time frame: 2 and 5 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.