Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated AML

• Status: Recruiting
• Trial end date: 2023-03-18
• Target enrollment: 0
• Participant gender: All

Summary

In this prospective study, 30 newly untreated elderly patients with acute myeloid leukemia(AML) who were not suitable for standard chemotherapy were enrolled to observe the efficacy and side effects of venetoclax (VEN) combined with azacytidine (AZA) and chemotherapy in newly treated elderly patients with AML. Overall survival (OS), complete remission rate/complete remission with incomplete recovery of blood cell count (CR/ CRi) were used as the primary endpoints, and time to response (TTR), duration of response (DOR), mortality, and recurrence rate were used as secondary endpoints,and the incidence of adverse events were evaluated.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LanZhou University
• Treatments: Azacitidine; Cladribine; Cytarabine; Idarubicin; Venetoclax

Criteria

Inclusion Criteria:

1. The elderly patients(≥ 60) with AML diagnosed according to WHO criteria;

2. Participants are ineligible for induction regimen;

3. The Eastern Cooperative Oncology Group (ECOG) performance status is 0-3;

4. The patients and their families agree and sign the informed consent form.

Exclusion Criteria:

1. Previous treatment for AML (including hypomethylating agents and other chemotherapy drugs);

2. Infiltration of the central nervous system;

3. Drugs use history affecting CYP3A within 7 days before enrollment;

4. participants considered by the investigator to be unsuitable for inclusion.