A Clinical Study of VA-CAG as Induction Therapy in Newly Diagnosed AML Patients

July 9, 2025 updated by: Hematology department of the 920th hospital

Venetoclax/Azacitidine/Low-Dose Cytarabine/Aclarubicin/G-CSF (VA-CAG) in Newly-Diagnosed Acute Myeloid Leukemia: A Phase-2, Multi-center, Prospective Clinical Study

This study aims to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine and CAG(VA-CAG) as induction regimen in newly diagnosed young patients with acute myeloid leukemia(AML).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, multicenter, phase II clinical trial to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine (VA) and CAG (G-CSF priming, low dose cytarabine, and aclarubicin) as induction regimen in newly diagnosed patients with acute myeloid leukemia (AML).

The combination of venetoclax and azacitidine is the standard therapy for elderly (> 60 year old) patients with newly diagnosed AML who are not eligible for intensive chemotherapy. Previous studies have shown that venetoclax plus intense chemotherapy represent promising efficacy in de novo AML patients with high complete remission rates and good tolerance. The preliminary results suggest that venetoclax in combination with azacitidine and CAG are well tolerated and effective for newly diagnosed young patients with AML. Thus, this phase II clinical trial is going to further explore its efficacy and safety. It is expected that about 100 patients will take part in this trial.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients ≥ 18 years old and ≤ 65 years old
  2. Newly diagnosed as AML patients according to 2016 World Health Organization (WHO) classification;
  3. Patients without receiving prior therapy for AML;
  4. Eastern Cooperative Oncology Group (ECOG) Performance status score less than 3;
  5. Liver function: Total bilirubin ≦2 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN
  6. Renal function：Ccr（Creatinine Clearance Rate） ≧30 ml/min; Scr (serum creatinine) ≦2 ULN
  7. Heart function: left ventricular ejection fraction ≧45%
  8. Patients must participate in this clinical trial voluntarily and sign an informed consent form.

Exclusion Criteria:

  1. Acute promyeloid leukemia；
  2. AML with central nervous system (CNS) infiltration；
  3. Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML；
  4. Patients with a life expectancy <3 months
  5. Patients with uncontrolled active infection;
  6. HIV infection;
  7. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment; b) An active second cancer that requires treatment within 6 months of study entry.
  8. Female who are pregnant, breast feeding or childbearing potential.
  9. Patients deemed unsuitable for enrollment by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group

Induction: Subjects who meet the enrollment conditions will receive Venetoclax plus Azacitidine and CAG(VA-CAG) . Participants will receive this induction Therapy as azacitidine on days 1-7, venetoclax aily on days 1-28, cytarabine q12h on days 1-7, aclacinomycin on days 1,3,5,7, and granulocyte colony-stimulating factor on days 0-8. Participants will receive second induction if not reach complete remission.

Consolidation: If patients are intermediate or poor risk and have plans for allogeneic hematopoietic stem-cell transplantation(allo-HSCT) , high dose cytarabine (3g/m2 q12h days 1-3) for 1-2 cycles and follow up with allo-HSCT. In other cases, high dose cytarabine for 4 cycles.
Drug: Venetoclax in combination with azacitidine and CAG

Induction:

VA regimen：

Drug: Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21);

Drug: Azacitidine 75 mg/m2 subcutaneously once daily on days 1-7.

CAG regimen：

Drug: Cytarabine 10mg/m2 subcutaneously q12h on days 1-7;

Drug: Aclacinomycin 12-14mg/m2 on days 1,3,5,7;

Drug: Granulocyte colony-stimulating factor 5ug/kg on days 0-8, discontinue if WBC >20×10^9/L；

Consolidation:

Drug: Cytarabine 3g/m2 q12h on days 1-3.

Other Names:
  • VA-CAG regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CR rate
Time Frame: At the end of Cycle 1 of induction (each cycle is about 30 days)
At the end of Cycle 1 of induction (each cycle is about 30 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: From the first day of induction until the starting day of the next cycle of therapy (up to 60 days）
Safety and tolerability analysis will be assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
From the first day of induction until the starting day of the next cycle of therapy (up to 60 days）
Duration of remission
Time Frame: From the date of the first remission until the date of relapse (assessed up to 30 months)
DOR was defined as the period from the time to acquire CR until relapse
From the date of the first remission until the date of relapse (assessed up to 30 months)
Minimal Residual Disease negative remission rate (MRD-negative rate)
Time Frame: After 1 cycle of induction (each cycle is about 30 days)
Percentage of participants who converted to MRD < 10^-3 by flow cytometry before initiation of consolidation therapy.
After 1 cycle of induction (each cycle is about 30 days)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From the first day of induction until the date of death from any cause, assessed up to 30 months
Overall Survival will be defined as the time from administration of the initial doses until death from any cause.
From the first day of induction until the date of death from any cause, assessed up to 30 months
Relapse-free survival
Time Frame: From the first day of induction until the date of relapse or the date of death from any cause, assessed up to 30 months
Relapse-free survival will be defined as the time since date of CR until either relapse or death in remission.
From the first day of induction until the date of relapse or the date of death from any cause, assessed up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hematology department of the 920th hospital

Investigators

  • Principal Investigator: Sanbin Wang, MD, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

December 10, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Actual)

December 23, 2022

Study Record Updates

Last Update Posted (Actual)

July 15, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMHD-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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