Venetoclax in Combination With Standard Induction and Consolidation Chemotherapy in Newly Diagnosed Young AML Patients

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Invitation-only

Conditions: Acute Myeloid Leukemia

Study type: Observational

Funder types: Other

Identifiers

NCT06162325

AML-VEN PLUS

Details and patient eligibility

About

The goal of this observational study is to to evaluate the efficacy and safety of Venetoclax in combination with DA60(daunorubicin 60 mg/m2/d for 3 days, and cytarabine 100 mg/m2 every 12 h for 7 days) induction and HD-AraC(cytarabine 3 g/m2 every 12 h for 3 days) consolidation, in young patients with newly diagnosed acute myeloid leukemia (AML).

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed, morphologically documented AML based on the World Health Organization (WHO) 2016 classification.
• Age ≥ 18 years and ≤ 59 years
• Have been treat with the "venetoclax in combination with standard induction and consolidation chemotherapy" therapy, and in follow-up.
• Be comprehensive of the research, and able to provide informed consent.

Exclusion criteria

• Diagnosis of acute promyelocytic leukemia (APL).
• Prior treatment for AML, except for: leukapheresis, hydroxyurea, and growth factor/cytokine.
• Unable to understand or participate.