Clinical trial · Interventional
Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia (AML) in Elderly Patients
A Randomized Study to Evaluate the Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients
NCT05188326CI-TRIAL-00067004completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Supportive Care | Other | — | UNRESOLVED |
| Vidaza 100 milligram (mg) injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Azacitidine
- description
- 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
- interventionNames
- Drug: Vidaza 100 milligram (mg) injection
- type
- PLACEBO_COMPARATOR
- label
- Best supportive care
- description
- No drug administration
- interventionNames
- Other: Best Supportive Care
Primary outcomes (1)
- measure
- Disease free Survival (DFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 61 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.