Clinical trial · Observational
Influence of Molecular Abnormalities on Response of VAH vs. VEN+HMA in RR-AML
Influence of Molecular Abnormalities on Treatment Response of the Regimen of Venetoclax Plus Azacytidine Combined With Homoharringtonine Versus Venetoclax Plus Hypomethylating Agents (HMA) in Relapsed/Refractory Acute Myeloid Leukemia
- 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 aim of this study is to reveal the influence of gene mutations on the treatment response of the regimen of HHT combined with Venetoclax plus AZA versus venetoclax plus HMA in the salvage therapy of RR-AML.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cytogenetic Abnormality | — | UNRESOLVED | — |
| Gene Abnormality | — | UNRESOLVED | — |
| Refractory Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Relapsed Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VAH regimen | Drug | — | UNRESOLVED |
| VEN+HMA regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- VAH group
- description
- Patients assigned to this group received one to two cycles of VAH regimen as salvage therapy of RR-AML.
- interventionNames
- Drug: VAH regimen
- label
- VEN+HMA group
- description
- Patients assigned to this group received one to two cycles of venetoclax plus HMA regimen as salvage therapy of RR-AML.
- interventionNames
- Drug: VEN+HMA regimen
Primary outcomes (1)
- measure
- CR/CRi
- timeFrame
- At the end of Cycle 2 (each cycle is 28 days)
- description
- Complete remission and CR with incomplete count recovery
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. RR-AML 2. Patients must have been treated for at least one cycle of VEN-based regimen and finished outcome assessment. Exclusion Criteria: 1. Acute promyelocytic leukemia (AML subtype M3) 2. Previous exposure to the treatment of VEN-based regimen 3. Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy) 4. Respiratory failure (PaO2 ≤60mmHg) 5. Hepatic abnormalities (total bilirubin ≥2 times the upper limit of normal \[ULN\], alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 times the ULN) 6. Renal dysfunction (creatinine ≥2 times the ULN or creatinine clearance rate \< 30 mL/min) 7. ECOG performance status 3, 4 or 5 8. Substantial history of neurological, psychiatric, endocrine, metabolic, immunological, or any other medical condition not suitable for the trial (investigators' decision) 9. Active acute or chronic graft-versus-host disease (GVHD). Active acute GVHD or chronic GVHD is defined as GVHD requiring either at least 1 mg/kg per day of prednisone (or equivalent) or treatment beyond systemic corticosteroids. 10. Patients with pregnancy 11. Uncontrolled active infection 12. Clinically significant coagulation abnormalities
References
Publications (0)
Data not yet available