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Acute Myeloid LeukemiaPhase 2NCT05659992

Clinical Study of Venetoclax Combined with CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

A Phase 2 study testing azacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte 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
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with CACAG 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;aclamycin;Chidamide;venetoclax;granulocyte
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
25 Dec 2022to 14 Aug 2024
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.
  • 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 0-3,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 active infection
  • 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: Single Arm,open Label,phase I Clinical Study of Venetoclax Combined with CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with CACAG 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. In order to improve the outcome of patients with de novo AML, participants developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, participants intent to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed AML.

Being tested
azacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte
Keywords
Venetoclax, CACAG, AML
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;aclamycin;Chidamide;venetoclax;granulocyteDrug

    1. azacytidine (75 mg/m2/day, days 1 to 7).
    2. cytarabine (75 mg/m2 bid, days 1 to 5).
    3. aclamycin (10 mg/m2/day, day1,3,5).
    4. Chidamide (30 mg/day , days 0,3).
    5. venetoclax (100 mg day 1, 200 mg day 2, 400mg days 3 to 14 ).
    6. granulocyte colony-stimulating factor (5ug/kg/day, day 0 until agranulocytosis recovery)
Study groups in NCT05659992
Study groupRoleWhat they receive
treatment groupExperimentalExperimental: Venetoclax combined CACAG regimen for newly diagnosed AML. All recipients in this arm received azacytidine, cytarabine.aclamycin, chidamide,venetoclax and granulocyte colony-stimulating factor.Azacytidine was uesd as 75 mg/m2/day from day-1 to day-7.Cytarabine was uesd as 75 mg/m2 bid from day-1 to day-5. Aclamycin was uesd as 10 mg/m2/day on day1,3,5). Chidamide was uesd as 30 mg/day twice per week for 2 weeks. Venetoclax was uesd as 100 mg on day 1, 200 mg on day 2, 400mg from day-3 to day-14.Granulocyte colony-stimulating factor was uesd as 5ug/kg/day from day 0 until agranulocytosis recovery.
Receives: Drug: azacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte

What is being measured

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

  1. Overall Response Rate (ORR)

    Defined as the percentage of participants achieving a best overall response of complete response (CR), CR with incomplete blood count recovery (CRi), or partial response (PR).

    Measured: 1 month after study treatment

Secondary outcomes (7)

  1. 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 or < 0.01% as assessed by PCR of a bone marrow aspirate.

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

  2. Progression Free Survival (PFS)

    PFS was defined as time from the date joining the clinical study to the date of disease progression (PD) or date of death due to any cause, whichever occurred first.

    Measured: 180 days after study treatment

  3. Overall Survival (OS)

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

    Measured: 180 days after study treatment

  4. Rate of Participants With Adverse Events

    Percentage of Participants with 3 or 4 grade Adverse Events reported through 28 days post last study medication administration.

    Measured: Through 28 days post last study medication administration

  5. Partial Remission (PR) Rate:

    All hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25 percent; and decrease of pre-treatment bone marrow blast percentage by at least 50 percent.

    Measured: 1 month after study treatment

  6. Complete Remission (CR) Rate

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

    Measured: 1 month after study treatment

  7. CR with Incomplete Blood Count Recovery Rate

    All CR criteria except for residual neutropenia (\&amp;lt;1.0 x 109/L (1000/µL)) or thrombocytopenia (\&amp;lt;100 x 109/L (100,000/µL)

    Measured: 1 month 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 posted21 Dec 2022
  2. Study start25 Dec 2022
  3. Primary completion14 Aug 2023
  4. Study completion14 Aug 2024

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05659992
Sponsor's protocol ID
S2022-240
Status last verified
Nov 2022
First submitted
5 Dec 2022
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu Q, Yang J, Lv L, Zhang X, Li M, Xu L, Huang S, Jing Y, Dou L. Phase 2 study of chidamide in combination with CAG and venetoclax-azacitidine in older patients with newly diagnosed acute myeloid leukemia. Front Immunol. 2025 Feb 26;16:1525110. doi: 10.3389/fimmu.2025.1525110. eCollection 2025.

    PubMed 40079007

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing azacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte 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 8 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 8 Nov 2024. 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) (time frame: 1 month after 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 NCT05659992, which also lists 1 linked publication.

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 8 Nov 2024.

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