Clinical trial · Interventional
Individualized Induction Therapy for Non-elderly Acute Myeloid Leukemia Patients With Adverse Risk Features
The Clinical Study of Individualized Induction Therapy for Non-elderly Patients With Acute Myeloid Leukemia and Adverse Risk Features Guided by Rapid Screening With FISH and NGS
- 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)
Individualized induction therapy will be applied to the non-elderly acute myeloid leukemia (AML) patients with adverse genetic risk features guided by rapid screening with fluorescence in situ hybridization (FISH) and next-generation sequencing (NGS), such as the combination of Venetoclax plus decitabine, and Sorafenib for patients with high (FMS)-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) allelic ratio. This study aims to improve induction therapy for non-elderly AML patients with adverse genetic risk features, reduce treatment-related complications, and improve overall survival.
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, Adult | Adult Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| venetoclax combined with decitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment regime
- description
- combination of venetoclax plus azacitidine, and Sorafenib for patients with high FLT3-ITD allelic ratio
- interventionNames
- Drug: venetoclax combined with decitabine
Primary outcomes (1)
- measure
- CR/CRi/morphologic leukemia free state (MLFS)
- timeFrame
- Study start date to study end date, or death, whichever comes first, up to 4 years
- description
- Complete remission/complete remission with incomplete count recovery/Morphologic Leukemia Free State(after one cycle or two cycles of induction therapy)
Secondary outcomes (3)
- measure
- Event Free Survival(EFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female, 59 \> =Age (years) \>= 18; 2. Newly diagnosed as AML patients according to World Health Organization (WHO) classification; 3. AML patients meet the adverse risk group according to 2017 European Leukemia Net risk stratification; 4. Patients have not received prior therapy for AML (except HU); 5. Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1, 2 ; 6. Liver function: Total bilirubin ≦3 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN(except extramedullary infiltration of leukemia) 7. Renal function:Ccr ≧30 ml/min; 8. Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent. Exclusion Criteria: 1. Acute promyeloid leukemia; 2. AML with central nervous system (CNS) infiltration; 3. Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML; 4. HIV infection; 5. Patients with severe heart failure (grade 3-4) ; 6. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a) Uncontrolled and/or active systemic infection (viral, bacterial or fungal); b) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. c)An active second cancer that requires treatment within 6 months of study entry 7. Patients deemed unsuitable for enrolment by the investigator; 8. Patients willing to receive intensive induction chemotherapy 9. Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen; 10. Patients reject to participate in the study.
References
Publications (0)
Data not yet available