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Acute Myeloid LeukemiaPhase 2NCT05662956

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

A Phase 2 study testing Venetoclax in combination with azacitidine and CAG in people with Acute Myeloid Leukemia, run by Hematology department of the 920th hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Venetoclax in combination with azacitidine and CAG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteChina
Study dates
1 Dec 2022to 30 Apr 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Acute promyeloid leukemia；
  • AML with central nervous system (CNS) infiltration；
  • Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML；
  • Patients with a life expectancy <3 months
  • Patients with uncontrolled active infection;
  • HIV infection;
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  • 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.
  • Female who are pregnant, breast feeding or childbearing potential.
  • Patients deemed unsuitable for enrollment by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

    Kunming, Yunnan, 650000

Other trials in China

About this study

Official title: 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).

Read the 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.

Being tested
Venetoclax in combination with azacitidine and CAG
Keywords
Venetoclax, Azacitidine, Granulocyte colony-stimulating factor(G-CSF), Cytarabine, Aclarubicin
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Venetoclax in combination with azacitidine and CAGDrug

    Also called VA-CAG regimen

    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.

Study groups in NCT05662956
Study groupRoleWhat they receive
Treatment groupExperimentalInduction: 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.
Receives: Drug: Venetoclax in combination with azacitidine and CAG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CR rate

    Measured: At the end of Cycle 1 of induction (each cycle is about 30 days)

Secondary outcomes (3)

  1. Adverse Events

    Safety and tolerability analysis will be assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: From the first day of induction until the starting day of the next cycle of therapy (up to 60 days）

  2. Duration of remission

    DOR was defined as the period from the time to acquire CR until relapse

    Measured: From the date of the first remission until the date of relapse (assessed up to 30 months)

  3. Minimal Residual Disease negative remission rate (MRD-negative rate)

    Percentage of participants who converted to MRD < 10^-3 by flow cytometry before initiation of consolidation therapy.

    Measured: After 1 cycle of induction (each cycle is about 30 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2022
  2. Study start1 Dec 2022
  3. Primary completion30 Dec 2024
  4. Study completion30 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05662956
Sponsor's protocol ID
KMHD-01
Status last verified
Jul 2025
First submitted
10 Dec 2022
Last updated
15 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Venetoclax in combination with azacitidine and CAG in people with Acute Myeloid Leukemia, run by Hematology department of the 920th hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CR rate (time frame: At the end of Cycle 1 of induction (each cycle is about 30 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05662956.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.

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