Clinical trial NCT05053425: Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated AML
Official title: Clinical Study of Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia
Bcl-2 Inhibitors
Azacytidine
Chemotherapy
Lead sponsor: LanZhou University
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Induction therapy: venetoclax d1 100mg, d2 200mg, d3-28 400mg, po; azacytidine 75mg/m2, d1-7, sc. Consolidation therapy: Regimen A or B was chosen according to the wishes of the patients. In addition, venetoclax was used for 14 days for positive minimal residual disease(MRD) and 7 days for MRD negative.

regimen A: the first two cycles: venetoclax 400mg, d1-7/14, po; cladribine 5mg/m2, d1-3, ivgtt; cytarabine 10mg/m2, q12h, d1-10, sc; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; regimen B: the first two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 100mg/m2, d1-5/7, ivgtt; idarubicin 8mg/m2, d1-2/3, ivgtt; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; If the patient's ECOG performance status ≥2, the reduction of regimen IA(cytarabine+idarubicin)was 5+2. Maintenance therapy: azacytidine 75mg/m2, d1-7, sc.

Eligibility 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: up to 16 months.
measure: CR/CRi
timeFrame: up to 16 months.
Secondary outcomes:
measure: Time to response
timeFrame: up to 16 months.
measure: Duration of response
timeFrame: up to 16 months.
measure: Mortality
timeFrame: up to 16 months.
measure: Recurrence rate
timeFrame: up to 16 months.
measure: Adverse events
timeFrame: Adverse events were assessed weekly during the first and second cycles, and every two cycles thereafter (each cycle is 28 days), up to 16 months.
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Long Zhao
state: Gansu
Study officials:
affiliation: The First Hospital of Lanzhou University,Lanzhou,Gansu,China
name: Long Zhao, M.M.
role: PRINCIPAL_INVESTIGATOR
References: