Acute Myeloid Leukemia (AML)Phase 2NCT07642453

VA-CAG Two-Week vs. Three-Week Regimen for Induction Remission in Newly Diagnosed Acute Myeloid Leukemia.

A Phase 2 study testing Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF. in people with Acute Myeloid Leukemia (AML), run by Hematology department of the 920th hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Objective: This clinical trial aims to compare the efficacy and safety of the VA-CAG regimen administered as a two-week schedule versus a three-week schedule for induction remission in acute myeloid leukemia (AML). Key Research Questions: 1. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Acute Myeloid Leukemia (AML)
What is being tested?: Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF.
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: No sites listed yet
Study dates: 1 Jun 2026to 1 Jun 2028
Phase: Phase 2
Are there results?: Not yet: the study is under way

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of acute myeloid leukemia confirmed according to NCCN guidelines;
Age 18-75 years;
Body weight 30-100 kg;
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3;
No significant organ dysfunction (echocardiographic ejection fraction >45%; bilirubin <2 times the upper limit of normal; AST and ALT <3 times the upper limit of normal; serum creatinine <2 times the upper limit of normal);
No severe infections;
Study participants voluntarily agree to participate in this clinical trial and sign an informed consent form.

Who cannot join

Patients with other types of diseases;
Patients with a projected survival of less than 1 month;
History of prior treatment;
Severe psychiatric or neurological disorders that impair the ability to provide informed consent and/or report or observe adverse events;
Other circumstances deemed unsuitable for enrollment by the investigator.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Wang sanbin contact

13187424131

1739701184@qq.com

About this study

Official title: VA-CAG Two-Week vs. Three-Week Regimen for Induction Remission in Newly Diagnosed Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Controlled Trial

Key Research Questions:

Is the efficacy of the two-week VA-CAG regimen equivalent to that of the three-week regimen in inducing remission in AML?
Does the two-week VA-CAG regimen reduce treatment-related adverse events compared to the three-week regimen? Methods: Researchers will compare the efficacy and safety of the two-week VA-CAG regimen with the three-week regimen for induction remission in AML. Study participants will be randomly assigned to receive standard treatment with either the two-week or three-week VA-CAG regimen. Patients are required to attend monthly follow-up visits for a total of one year. At each follow-up, the following assessments will be performed: complete blood count, liver and kidney function tests, bone marrow aspiration, flow cytometric measurement of minimal residual disease (MRD), and/or fusion gene analysis, along with monitoring of other efficacy endpoints and adverse reactions.

Conditions: Acute Myeloid Leukemia (AML)
Being tested: Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF.
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,Azacitidine,Arubicin,Cytarabine,G-CSF.Drug
Specific Medication for the VACAG Protocol:
1. Two-week regimen group Azacitidine: 75 mg/m² on days 1-7 by subcutaneous injection, Venetoclax: 100 mg on Day 1, 200 mg on Day 2, 400 mg on Days 3-14, oral, Arubicin: 12-14 mg/m² on days 1, 3, 5, and 7 (IV infusion), Cytarabine: 10 mg/m² every 12 hours on days 1-7, subcutaneous injection, G-CSF: 5 μg/kg on days 0-8; discontinue if WBC > 20 × 10⁹/L;
2. Three-week regimen group Venetoclax administered for 21 days; dosage and administration are the same as in the 2-week regimen group.

Study groups in NCT07642453
Study group	Role	What they receive
2-week VACAG regimen for newly diagnosed acute myeloid leukemia	Experimental	Specific Medication for the 2-week VACAG regimen Protocol: Azacitidine: 75 mg/m² on days 1-7 by subcutaneous injection, Venetoclax: 100 mg on Day 1, 200 mg on Day 2, 400 mg on Days 3-14, oral, Arubicin: 12-14 mg/m² on days 1, 3, 5, and 7 (IV infusion), Cytarabine: 10 mg/m² every 12 hours on days 1-7, subcutaneous injection, Recombinant human granulocyte colony-stimulating factor: 5 μg/kg on days 0-8; discontinue if WBC > 20 × 10⁹/L; Receives: Drug: Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF.
3-week VACAG regimen for newly diagnosed acute myeloid leukemia	Active comparator	Specific Medication for the 3-week VACAG regimen Protocol: Azacitidine: 75 mg/m² on days 1-7 by subcutaneous injection, Venetoclax: 100 mg on Day 1, 200 mg on Day 2, 400 mg on Days 3-21, oral, Arubicin: 12-14 mg/m² on days 1, 3, 5, and 7 (IV infusion), Cytarabine: 10 mg/m² every 12 hours on days 1-7, subcutaneous injection, Recombinant human granulocyte colony-stimulating factor: 5 μg/kg on days 0-8; discontinue if WBC > 20 × 10⁹/L; Receives: Drug: Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF.

What is being measured

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

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

Secondary outcomes (3)

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）
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)
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 Jun 20261 Jun 2028

First posted11 Jun 2026
Study start1 Jun 2026 (estimated)
Primary completion1 Jun 2028 (estimated)
Study completion1 Jun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 110 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07642453
Sponsor's protocol ID: km-09
Status last verified: Jun 2026
First submitted: 31 May 2026
Last updated: 11 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: VA-CAG Two-Week vs. Three-Week Regimen for Induction Remission in Newly Diagnosed Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07642453
Acronym / sponsor ID: km-09
Conditions: Acute Myeloid Leukemia (AML)
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 110 participants (estimated)
Lead sponsor: Hematology department of the 920th hospitalUniversity, hospital or other
Study start: 1 Jun 2026 (estimated)
Primary completion: 1 Jun 2028 (estimated)
Study completion: 1 Jun 2028 (estimated)
First posted: 11 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Key Research Questions:

Is the efficacy of the two-week VA-CAG regimen equivalent to that of the three-week regimen in inducing remission in AML?
Does the two-week VA-CAG regimen reduce treatment-related adverse events compared to the three-week regimen? Methods: Researchers will compare the efficacy and safety of the two-week VA-CAG regimen with the three-week regimen for induction remission in AML. Study participants will be randomly assigned to receive standard treatment with either the two-week or three-week VA-CAG regimen. Patients are required to attend monthly follow-up visits for a total of one year. At each follow-up, the following assessments will be performed: complete blood count, liver and kidney function tests, bone marrow aspiration, flow cytometric measurement of minimal residual disease (MRD), and/or fusion gene analysis, along with monitoring of other efficacy endpoints and adverse reactions.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
2-week VACAG regimen for newly diagnosed acute myeloid leukemia	Experimental	Drug: Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF.Specific Medication for the 2-week VACAG regimen Protocol: Azacitidine: 75 mg/m² on days 1-7 by subcutaneous injection, Venetoclax: 100 mg on Day 1, 200 mg on Day 2, 400 mg on Days 3-14, oral, Arubicin: 12-14 mg/m² on days 1, 3, 5, and 7 (IV infusion), Cytarabine: 10 mg/m² every 12 hours on days 1-7, subcutaneous injection, Recombinant human granulocyte colony-stimulating factor: 5 μg/kg on days 0-8; discontinue if WBC > 20 × 10⁹/L;
3-week VACAG regimen for newly diagnosed acute myeloid leukemia	Active comparator	Drug: Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF.Specific Medication for the 3-week VACAG regimen Protocol: Azacitidine: 75 mg/m² on days 1-7 by subcutaneous injection, Venetoclax: 100 mg on Day 1, 200 mg on Day 2, 400 mg on Days 3-21, oral, Arubicin: 12-14 mg/m² on days 1, 3, 5, and 7 (IV infusion), Cytarabine: 10 mg/m² every 12 hours on days 1-7, subcutaneous injection, Recombinant human granulocyte colony-stimulating factor: 5 μg/kg on days 0-8; discontinue if WBC > 20 × 10⁹/L;

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Diagnosis of acute myeloid leukemia confirmed according to NCCN guidelines;
Age 18-75 years;
Body weight 30-100 kg;
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3;
No significant organ dysfunction (echocardiographic ejection fraction >45%; bilirubin <2 times the upper limit of normal; AST and ALT <3 times the upper limit of normal; serum creatinine <2 times the upper limit of normal);

Key exclusion criteria (5 listed)

Patients with other types of diseases;
Patients with a projected survival of less than 1 month;
History of prior treatment;
Severe psychiatric or neurological disorders that impair the ability to provide informed consent and/or report or observe adverse events;
Other circumstances deemed unsuitable for enrollment by the investigator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF.Specific Medication for the VACAG Protocol: 1. Two-week regimen group Azacitidine: 75 mg/m² on days 1-7 by subcutaneous injection, Venetoclax: 100 mg on Day 1, 200 mg on Day 2, 400 mg on Days 3-14, oral, Arubicin: 12-14 mg/m² on days 1, 3, 5, and 7 (IV infusion), Cytarabine: 10 mg/m² every 12 hours on days 1-7, subcutaneous injection, G-CSF: 5 μg/kg on days 0-8; discontinue if WBC > 20 × 10⁹/L; 2. Three-week regimen group Venetoclax administered for 21 days; dosage and administration are the same as in the 2-week regimen group.	Drug	2-week VACAG regimen for newly diagnosed acute myeloid leukemia, 3-week VACAG regimen for newly diagnosed acute myeloid leukemia

Primary outcome

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

3 secondary outcomes

Adverse Events
Time frame: 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)
Minimal Residual Disease negative remission rate (MRD-negative rate)
Time frame: After 1 cycle of induction (each cycle is about 30 days)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Wang sanbin contact

13187424131

1739701184@qq.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Venetoclax,Azacitidine,Arubicin,Cytarabine,G-CSF. in people with Acute Myeloid Leukemia (AML), run by Hematology department of the 920th hospital.

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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Wang sanbin (13187424131, 1739701184@qq.com), or a site near the patient. 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 NCT07642453.

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 11 Jun 2026.