Venetoclax + Decitabine vs. "7+3" Induction Chemotherapy in Young AML

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This research is being done to assess the therapeutic efficacy and safety of a promising (venetoclax and decitabine) versus conventional "7+3"chemotherapy in induction young patients with acute myeloid leukemia.

This study involves the following:

Venetoclax and decitabine (investigational combination) Cytarabine and idarubicin (per standard of care)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chen Suning
• Treatments: Cytarabine; Decitabine; Idarubicin; 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. Patients have not received prior therapy for AML (except hydroxyurea and Ara-C<1.0g/d);

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

5. 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)

6. Renal function：Ccr（Creatinine Clearance Rate） ≧30 ml/min;

7. 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.