Single Arm Study of Azacitidine and Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients

NCT05471700 | Completed

• 1 other identifier: AZA+Venetoclax
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to evaluate the safety and efficacy of Azacytidine in combination with Venetoclax in patients with newly diagnosed fit acute myeloid leukemia.

Conditions

Leukemia, Myeloid, Acute

Keywords

Acute Myeloid Leukemia; Newly Diagnosed AML; Azacitidine; Venetoclax; Induction Therapy

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR is defined as the percentage of participants who achieve the CR + CRi + Partial Remission (PR) as evaluated by the investigator.

  Up to 36 months

Secondary Outcomes (5)

• Minimal residual disease (MRD) negative response rate

  Up to 36 months

• Duration of Remission (DOR)

  Up to 36 months

• Allogeneic Hematopoietic Stem Cell Transplantation Rate

  Up to 36 months

• Overall Survival (OS)

  Up to 36 months

• Event-Free Survival (EFS)

  Up to 36 months

Study Arms (1)

Azacitidine combined with Venetoclax

EXPERIMENTAL

Each course is 28 days long. Subjects with newly diagnosed AML receive Venetoclax once daily by oral. The doses of Venetoclax is 100 mg on Day 1, 200 mg on Day 2, reaching a target dose of 400 mg on Day 3 and continuing through Day 28. If concomitantly receiving azoles, the dose of Venetoclax will be adjusted according to the instructions. At the same time patients will receive Azacitidine 75mg/m2 subcutaneous on Days 1-7.The induction therapy includes 1-2 cycle until subjects get remission. Once complete remission, subjects will receive consolidation. Azacitidine combined with Venetoclax or middle to high dose of arabinoside based chemotherapy would be given at the discretion of the physician.

Drug: Azacitidine; Drug: Venetoclax

Interventions

Azacitidine DRUG

Subjects will receive Azacitidine 75 mg/m2 on days 1-7.Each course is 28 days long.

Also known as: 5-Azacitidine, 5-aza

Azacitidine combined with Venetoclax

Venetoclax DRUG

Subjects would receive Venetoclax once daily by oral. The doses of Venetoclax is 100 mg on Day 1, 200 mg on Day 2, reaching a target dose of 400 mg on Day 3 and continuing through Day 28. Each course is 28 days long.

Also known as: Venclexta, Venclyxto

Azacitidine combined with Venetoclax

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45 to 65 years old,both male and female
• Be able to understand and sign informed consent
• Untreated AML patients (non-APL) diagnosed according to the 2016 World Health Organization (WHO) classification and diagnostic criteria for acute myeloid leukemia
• Patients with an ECOG performance status 0,1,2 or 3
• Expected survival time≥3 months
• Laboratory indicators meet the following standards:
• Bilrubin, ALT and AST were all less than 3 times the upper limit of normal within 7 days before the first day of treatment
• Serum creatinine clearance rate is greater than 30ml/min

You may not qualify if:

• patients participating in other interventional or observational clinical studies currently
• Patients has a history of myeloproliferative neoplasm \[MPN\]
• Patients with acute promyelocytic leukemia
• Active CNS involvement in patients with acute myeloid leukemia
• Patients with active hepatitis B or C, HIV infection before enrollment
• Cardiovascular status of patients evaluate by NYHA classification method \> 2
• Patients have chronic respiratory disease requiring continuous oxygen treatment, or any sitiuation investigator believes will adversely affect this study (including renal, neurological, psychiatric, endocrine, metabolic, immune, hepatic, cardiovascular disease and known history of allergy to any study drug)
• Patients suffering from malabsorption syndrome or other diseases that prevent the enteral route of administration
• patients present with an uncontrolled systemic infection (viral, bacterial, or fungal)
• Patients with a history of other malignancies within 2 years before enrollment, except for the following cases:
• Adequately treated carcinoma in situ of the cervix or carcinoma of the breast
• Basal cell carcinoma or localized squamous cell carcinoma of skin

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guanzhou, Guandong, 510250, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine; venetoclax

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

Study Officials

• Yuhua Li, Doctor

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 25, 2022
• Study Start: September 1, 2022
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: September 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available and permanently disclosed within 6 months after the trial.
• Access Criteria: You can log in to the website for data access or contact us for data.

Locations

CN (1)