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

• Status: Completed
• Trial end date: 2021-09-27
• Target enrollment: 0
• Participant gender: All

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 CR following conventional induction ('3+7') and consolidation chemotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Associazione Qol-one
• Treatments: Azacitidine

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 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.