Individualized Induction Therapy for Non-elderly AML Patients With Adverse Risk Features

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Individualized induction therapy will be applied to the non-elderly 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Treatments: Decitabine; Sorafenib; Venetoclax

Criteria

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. ECOG(Eastern Cooperative Ocology Group) Performance status of 0,1, 2 ;

6. Liver function: Total bilirubin ≦3 ULN(upper limit of normal); AST(aspartate aminotransferase ) ≦3 ULN; ALT (alanine aminotransferase)≦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 CNS(central nervous system) infiltration；

3. Patients have received prior HMA therapy for MDS (myelodysplastic syndrome) 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.