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

Acute Myeloid Leukemia Clinical Trial

Official title:

Clinical Study of Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated Acute Myeloid Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05053425
• Other study ID #: CSBCL2
• Secondary ID: ChiCTR2100045330
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: March 18, 2023

Study information

• Verified date: April 2022
• Source: LanZhou University
• Contact: Long Zhao, M.M.
• Phone: +18919128021
• Email: zhaodragon[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 18, 2023
• Est. primary completion date: January 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Venetoclax
given po.
• Azacitidine
given sc.
• Cladribine
given ivgtt.
• Cytarabine
given sc or ivgtt.
• Idarubicin
given ivgtt.

Locations

Country	Name	City	State
China	Long Zhao	Lanzhou	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
LanZhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	Overall survival will be defined as the number of days from the date of first dose to the date of death.	up to 16 months.
Primary	CR/CRi	To assess the percentage of patients achieving CR/CRi according to the International Working Group criteria for AML.	up to 16 months.
Secondary	Time to response	To assess the percentage of patients achieving CR/CRi or partial remission (PR) according to the International Working Group criteria for AML.	up to 16 months.
Secondary	Duration of response	Duration of response will be defined as the number of days from the date of first response per the IWG criteria for AML to the earliest recurrence or progressive disease.	up to 16 months.
Secondary	Mortality	The proportion of patients from enrollment to death was recorded.	up to 16 months.
Secondary	Recurrence rate	Record the proportion of patients with recurrence in the study.	up to 16 months.
Secondary	Adverse events	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.	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.