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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: Vidaza 100 milligram (mg) injection
* Other: Best Supportive Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 61 years or more Newly diagnosed AML with > 30% myeloid marrow blasts, either de novo or evolving from a MDS not previously treated with chemotherapeutic agents. Absence of central nervous system involvement No contraindications for intensive chemotherapy, defined as: prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range; a creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related; a Performance Status (PS) score of > 2; uncontrolled severe infection. Informed consent. Exclusion Criteria: Age ≤ 60 years Newly diagnosed AML with < 30% myeloid marrow blasts Previously treated AML Central nervous system involvement Prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range; A creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related; A PS score of > 2; Uncontrolled severe infection.

Ages Eligible for Study
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Minimum Age: 61 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azacitidine<br>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 | Drug: Vidaza 100 milligram (mg) injection<br>* 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.<br>* Other names: Vidaza;|
| Placebo Comparator: Best supportive care<br>No drug administration | Other: Best Supportive Care<br>* Best supportive care includes antibiotics, transfusions and fluids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalizations | Number and length of hospitalizations in the post-remission period. | 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 | 2 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myeloid Leukemia,, Post-Remission Therapy