Clinical trial · Interventional
Study of DAC Combined With HAAG Regimen in Newly Diagnosed AML Patients Older Than 60
A Phase 3, Open Label, Single Arm, Multi-Center Study to Evaluate the Efficacy and Safety of Decitabine Combined With HAAG Regimen in Elderly Newly Diagnosed Acute Myeloid Leukemia Patients.
NCT04083911CI-TRIAL-00040481unknownPhase 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 older 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decitabine, Homoharringtonine, Aclarubicin, Cytarabine and G-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Decitabine combined with HAAG Regimen
- description
- This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in elderly newly diagnosed AML patients.
- interventionNames
- Drug: Decitabine, Homoharringtonine, Aclarubicin, Cytarabine and G-CSF
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Day 28-35 of induction course
- description
- ORR includes complete response (CR), CRi and PR. CR was defined as \< 5% bone marrow blasts in an aspirate with spicules, no blasts with Auer rods or persistence of extramedullary disease, and independent of transfusions; CRi: was defined as\<5% bone marrow blasts, either ANC\<1×10\^9/L or platelets\<100×10\^9/L, transfusion independence but with persistence of cytopenia; PR was defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate and the normalization of blood counts.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia. 2. 60-79 years old. 3. ECOG score: 0-3. 4. No history of previous chemotherapy or target therapy. 5. Provide informed consent. Exclusion Criteria: 1. Patients have acute promylocytic leukemia or chronic myeloid leukemia in blast crisis. 2. Patients with another malignant disease. 3. Patients with uncontrolled active infection. 4. Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification. 5. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL. 6. Patients with creatinine clearance rate \< 50ml/min. 7. Patients with active hepatitis B or hepatitis C infection. 8. Patients with HIV infection. 9. 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.