Acute Myeloid Leukemia
Conditions
Keywords
Acute Myeloid Leukemia,, Post-Remission Therapy
Brief 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 complete remission (CR) following conventional induction ('3+7') and consolidation chemotherapy.
Detailed description
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
Interventions
DRUGVidaza 100 milligram (mg) injection
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.
OTHERBest Supportive Care
Best supportive care includes antibiotics, transfusions and fluids
Sponsors
Associazione Qol-one
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
61 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free Survival (DFS) | 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalizations | 5 years | Number and length of hospitalizations in the post-remission period. |
| Overall Survival (OS) | 2 and 5 years | 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 |
Countries
Italy
Outcome results
None listed