Venetoclax Plus CACAG Regimen for Newly Diagnosed Acute Myeloid Leukemia

NCT ID: NCT06068621

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-08-31

Brief 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.

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Venetoclax Combined With CACAG Regimen

Venetoclax 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 .

Group Type: EXPERIMENTAL

Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor

Intervention Type: DRUG

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" Regimen

Idarubicin+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.

Group Type: ACTIVE_COMPARATOR

"3+7"

Intervention Type: DRUG

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.

Interventions

Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor

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)

Intervention Type: DRUG

"3+7"

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.

Intervention Type: DRUG

Other Intervention Names

CACAG+VEN; IA or DA

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• 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.)

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

940 Hospital of the People's Liberation Army Joint Logistic Support Force

OTHER

Sponsor Role: collaborator

The General Hospital of Western Theater Command

OTHER

Sponsor Role: collaborator

The General Hospital of Northern Theater Command

OTHER

Sponsor Role: collaborator

The 960th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army

UNKNOWN

Sponsor Role: collaborator

Air Force Military Medical University, China

OTHER

Sponsor Role: collaborator

Yantai Yuhuangding Hospital

OTHER

Sponsor Role: collaborator

People's Liberation Army (PLA) Strategic Support Force Characteristic Medical Center

UNKNOWN

Sponsor Role: collaborator

First Hospital of China Medical University

OTHER

Sponsor Role: collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Daihong Liu

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daihong Liu, doctor

Role: STUDY_CHAIR

Chinese PLA General Hospital

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

S2023-056-01

Identifier Type: -

Identifier Source: org_study_id