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

NCT05053425 | Unknown

• 2 other identifiers: CSBCL2ChiCTR2100045330
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; Bcl-2 Inhibitors; Azacytidine; Chemotherapy

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (5)

• Time to response

  up to 16 months.

• Duration of response

  up to 16 months.

• Mortality

  up to 16 months.

• Recurrence rate

  up to 16 months.

• Adverse events

  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.

Study Arms (1)

Venetoclax group

EXPERIMENTAL

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.

Drug: Venetoclax; Drug: Azacitidine; Drug: Cladribine; Drug: Cytarabine; Drug: Idarubicin

Interventions

Venetoclax DRUG

given po.

Also known as: ABT-199

Venetoclax group

Azacitidine DRUG

given sc.

Also known as: 5-Azacytidine

Venetoclax group

Cladribine DRUG

given ivgtt.

Also known as: 2-CdA

Venetoclax group

Cytarabine DRUG

given sc or ivgtt.

Also known as: Ara-c

Venetoclax group

Idarubicin DRUG

given ivgtt.

Also known as: Idamycin®

Venetoclax group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The elderly patients(≥ 60) with AML diagnosed according to WHO criteria;
• Participants are ineligible for induction regimen;
• The Eastern Cooperative Oncology Group (ECOG) performance status is 0-3;
• The patients and their families agree and sign the informed consent form.

You may not qualify if:

• Previous treatment for AML (including hypomethylating agents and other chemotherapy drugs);
• Infiltration of the central nervous system;
• Drugs use history affecting CYP3A within 7 days before enrollment;

Sponsors & Collaborators

• LanZhou University: lead

Study Sites (1)

Long Zhao

Lanzhou, Gansu, 730000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; Azacitidine; Cladribine; Cytarabine; Idarubicin

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; 2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyadenosines; Deoxyribonucleosides; Arabinonucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Long Zhao, M.M.

  The First Hospital of Lanzhou University,Lanzhou,Gansu,China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Long Zhao, M.M.

CONTACT

+18919128021; zhaodragon@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor-in-charge, Master of Medicine

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 22, 2021
• Study Start: October 20, 2021
• Primary Completion: January 18, 2023
• Study Completion: March 18, 2023
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)