Clinical trial · Interventional
Study of DAC Combined With HAAG Regimen in Newly Diagnosed Younger AML Patients
A Phase 3, Randomized, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Decitabine Combined With HAAG Regimen in Newly Diagnosed Acute Myeloid Leukemia Patients Younger Than 60 Years
NCT04087967CI-TRIAL-00040574unknownPhase 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 purpose of this study is to evaluate the safety and efficacy of DAC combined with HAAG regimen in the induction treatment of newly diagnosed AML patients younger than 60 years.
Conditions
Conditions (2)
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 |
| Induction Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decitabine plus HAAG regimen | Drug | — | UNRESOLVED |
| Idarubicine plus Cytarabine regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Decitabine combined with HAAG
- description
- This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed AML patients younger than 60.
- interventionNames
- Drug: Decitabine plus HAAG regimen
- type
- ACTIVE_COMPARATOR
- label
- IA Regimen
- description
- This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed AML patients younger than 60.
- interventionNames
- Drug: Idarubicine plus Cytarabine regimen
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia. 2. Age 18-59. 3. ECOG score: 0-2. 4. Treatment related or secondary AML. 5. No history of previous chemotherapy or target therapy. 6. Provide informed consent. Exclusion Criteria: 1. Patients are pregnant or lactating. 2. Patients have acute promylocytic leukemia or chronic myeloid leukemia in blast crisis. 3. Patients with another malignant disease. 4. Patients with uncontrolled active infection. 5. Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification. 6. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL. 7. Patients with creatinine clearance rate \< 50ml/min. 8. Patients with active hepatitis B or hepatitis C infection. 9. Patients with HIV infection. 10. Patients with other commodities that the investigators considered not suitable for the enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.