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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019710-24-IT

Enrollment

Registered

2010-06-21

Start date

2010-09-01

Completion date

Unknown

Last updated

2022-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACUTE MYELOID LEUKEMIA PATIENTS MedDRA version: 12.1 Level: LLT Classification code 10000880 Term: Acute myeloid leukaemia

Interventions

Trade Name: Azacitidina Pharmaceutical Form: Powder for suspension for injection INN or Proposed INN: AZACITIDINE CAS Number: 320-67-2 Concentration unit: mg/ml milligram(s)/millilitre Concentration

Eligibility

Sex/Gender

All

Inclusion 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: 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

Exclusion criteria: 1. Age = 60 years 2. Newly diagnosed AML with 2; 8. Uncontrolled severe infection

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 17, 2026