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

Phase 1

• Conditions: ACUTE MYELOID LEUKEMIA PATIENTS; MedDRA version: 12.1Level: LLTClassification code 10000880Term: Acute myeloid leukaemia

• Registration Number: EUCTR2010-019710-24-IT
• Lead Sponsor: ASSOCIAZIONE QOL-ONE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-21
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 95

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: a) prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range; b) a creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related; c) a PS score of > 2; d) uncontrolled severe infection. 5. Informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate 1. Overall survival (OS) at 2 years. Event for OS in both arms is death and patients are censored at the date of last contact if alive. 2. Disease-free survival (DFS) at 2 years. Events for DFS in both arms are death and first relapse (either AML or MDS recurrence). 3. Changes in quality of life from diagnosis in both arms.;Secondary Objective: To evaluate 1. Number and length of hospitalizations in the 2 arms in the 2-year post-remission period.;Primary end point(s): 1. Differences in OS at 2 years between 5-Aza and placebo arms. 2. Differences in DFS at 2 years between 5-Aza and placebo arms. 3. Differences in changes in QoL scores from diagnosis between 5-Aza and placebo arms.