AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 2NCT06068621

Venetoclax Plus CACAG Regimen for Newly Diagnosed Acute Myeloid Leukemia

A Phase 2 study testing Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor and "3+7" in people with Acute Myeloid Leukemia, run by Chinese PLA General 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
Search all trials

Trial summary

The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia. Read more about this study

Who is it for?
Ages 14 to 75 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor and "3+7"
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
1 Mar 2023to 31 Aug 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 14 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients who are able to understand and willing to sign the informed consent form (ICF).
  • All patients should aged 14 to75 years,no gender limitation.
  • Patients who are newly diagnosed with AML(no M3).
  • Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal;
  • Renal function: creatinine ≤the upper limit of normal;
  • Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
  • The score of Eastern Cooperative Oncology Group (ECOG) is 0-2, and the predicted survival ≥ 4 months.
  • Patients without severe allergic constitution.

Who cannot join

  • Patients with allergy or contraindication to the study drug;
  • Female patients who are pregnant or breast-feeding.
  • Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment;
  • Patients with mental illness or other states unable to comply with the protocol;
  • Less than 6 weeks after surgical operation of important organs.
  • Liver function: ALT and AST>2.5 times the upper limit of normal ,bilirubin> 2 times the upper limit of normal;Renal function: creatinine >the upper limit of normal;
  • The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

Other trials in China

About this study

Official title: Multicenter,Open Label,Phase 2 Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia.

Read the detailed description

Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor.Over the past years, combination chemotherapy with anthracycline and standard dose cytarabine (standard "3+7" induction therapy) remains the standard induction. In order to improve the outcome of patients with de novo AML, we developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, we intent to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia.

Being tested
Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor, "3+7"
Keywords
Acute Myeloid Leukemia, First Line Therapy
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.

  • Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factorDrug

    Also called CACAG+VEN

    1. Azacytidine (75 mg/m2/day, days 1 to 7).
    2. Cytarabine (75-100 mg/m2 bid, days 1 to 5).
    3. Aclacinomycin(20 mg/day, days 1,3,5).
    4. Chidamide (30 mg/day , days 1,4,8,11).
    5. Venetoclax (400 mg/day, days 1 to 14,Combined with posaconazole reduced to 100 mg/day,Combined with voriconazole reduced to 200 mg/day ).
    6. Granulocyte colony-stimulating factor (300 μg/day, day 0 until agranulocytosis recovery)

  • "3+7"Drug

    Also called IA or DA

    IA regimen:

    1. Idarubicin (8-10 mg/m2) for 3 days .
    2. Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.

    DA regimen:

    1. Daunorubicin(60 mg/m2) for 3 days.
    2. Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.
Study groups in NCT06068621
Study groupRoleWhat they receive
Venetoclax Combined With CACAG RegimenExperimentalVenetoclax combined with CACAG regimen for newly diagnosed AML. Recipients were randomized and those entering the experimental group received azacytidine, cytarabine,aclacinomycin,chidamide,venetoclax and granulocyte colony-stimulating factor. Azacytidine was used as 75 mg/m2/day from day 1 to day 7. Cytarabine was used as 75-100 mg/m2 bid from day 1 to day 5. Aclacinomycin was used as 20 mg/day on days 1,3,5. Chidamide was used as 30 mg/day on days 1,4,8,11. Venetoclax was used as 400 mg/day from day 1 to day 14;Combined with posaconazole, reduced to 100 mg/day;Combined with voriconazole, reduced to 200 mg/day.Granulocyte colony-stimulating factor was used as 300 μg/day from day 0 until agranulocytosi recovery .
Receives: Drug: Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor
"3+7" RegimenActive comparatorIdarubicin+cytarabine(IA) regimen or daunorubicin+cytarabine(DA) regimen for newly diagnosed AML.Recipients were randomized and those entering this group received IA or DA induction chemotherapy. With the IA regimen,recipients received idarubicin(8-10 mg/m2) for three days and cytarabine(75-100 mg/m2, every 12 hrs) for seven days. With the DA regimen,recipients received daunorubicin(60 mg/m2)for three days and cytarabine(75-100 mg/m2,every 12 hrs)for seven days.
Receives: Drug: "3+7"

What is being measured

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

  1. Overall Response Rate (ORR) after 1 course of treatment

    Defined as the percentage of participants achieving a best overall response of complete response (CR) or CR with incomplete blood count recovery (CRi).Biological characteristics exploratory studies were analyzed by single-cell sequencing and Atac-seq. Further, according to European LeukemiaNet risk group, we analyzed the outcomes of patients by molecular subtype as a sub-group analysis.

    Measured: 1 months after the start of study treatment

Secondary outcomes (9)

  1. Complete Remission (CR) Rate after 1 course of treatment

    Defined in accordance with the IWG Response Criteria in AML. Bone marrow blasts<5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0 x 109/L (1000/µL); platelet count >100 x 109/L (100,000/µL); independence of red cell transfusions.

    Measured: 2 months after study treatment

  2. Complete Remission (CR) Rate after 2 courses of treatment

    Defined in accordance with the IWG Response Criteria in AML. Bone marrow blasts<5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0 x 109/L (1000/µL); platelet count >100 x 109/L (100,000/µL); independence of red cell transfusions.

    Measured: after two courses of chemotherapy (each course is 28 days)

  3. Overall Response Rate (ORR) after 2 course of treatment

    Defined as the percentage of participants achieving a best overall response of complete response (CR) or CR with incomplete blood count recovery (CRi).Biological characteristics exploratory studies were analyzed by single-cell sequencing and Atac-seq. Further, according to European LeukemiaNet risk group, we analyzed the outcomes of patients by molecular subtype as a sub-group analysis.

    Measured: after two courses of chemotherapy (each course is 28 days)

  4. Rate of Minimal Residual Disease (MRD)-Negative Response

    Percentage of participants who achieved MRD-negative response, defined as < 1 leukemia cell per 10,000 leukocytes as assessed by flow cytometry.

    Measured: after two courses of chemotherapy (each course is 28 days)

  5. Event-free survival

    Defined as the time interval from treatment initiation to the occurrence of induction failure,relapse,or death,whichever came first.

    Measured: 180 days after study treatment

  6. Overall Survival (OS)

    Defined as the time from joining the clinical study to death due to any cause.

    Measured: 180 days after study treatment

  7. Treatment-related adverse events

    Defined as adverse events that occurred from the first dose of study treatment to 30 days after the discontinuation of treatment.

    Measured: From the first dose of study treatment to 30 days after the discontinuation of treatment

  8. Early death

    Defined as death within 30 days of chemotherapy.

    Measured: Within 30 days of the start of the first course of treatment

  9. Disease-free survival

    Defined as the time interval from disease remission to the occurrence of relapse or death,whichever came first.

    Measured: 180 days after study treatment

Timeline

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

  1. First posted5 Oct 2023
  2. Study start1 Mar 2023
  3. Primary completion31 May 2024
  4. Study completion31 Aug 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06068621
Sponsor's protocol ID
S2023-056-01
Status last verified
Jan 2026
First submitted
29 Sep 2023
Last updated
20 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor and "3+7" in people with Acute Myeloid Leukemia, run by Chinese PLA General 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 7 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 20 Jan 2026. 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?

Overall Response Rate (ORR) after 1 course of treatment (time frame: 1 months after the start of study treatment). 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 NCT06068621.

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 20 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in