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

NCT ID: NCT05662956

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2025-04-30

Brief 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).

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Induction: 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.

Group Type: EXPERIMENTAL

Venetoclax in combination with azacitidine and CAG

Intervention Type: DRUG

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.

Interventions

Venetoclax in combination with azacitidine and CAG

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.

Intervention Type: DRUG

Other Intervention Names

VA-CAG regimen

Eligibility Criteria

Inclusion Criteria

1. Patients ≥ 18 years old and ≤ 65 years old

2. Newly diagnosed as AML patients according to 2016 World Health Organization (WHO) classification;

3. Patients without receiving prior therapy for AML;

4. Eastern Cooperative Oncology Group (ECOG) Performance status score less than 3;

5. Liver function: Total bilirubin ≦2 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN

6. Renal function：Ccr（Creatinine Clearance Rate） ≧30 ml/min; Scr (serum creatinine) ≦2 ULN

7. Heart function: left ventricular ejection fraction ≧45%

8. Patients must participate in this clinical trial voluntarily and sign an informed consent form.

Exclusion Criteria

1. Acute promyeloid leukemia；

2. AML with central nervous system (CNS) infiltration；

3. Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML；

4. Patients with a life expectancy <3 months

5. Patients with uncontrolled active infection;

6. HIV infection;

7. 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.

8. Female who are pregnant, breast feeding or childbearing potential.

9. Patients deemed unsuitable for enrollment by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hematology department of the 920th hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanbin Wang, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Kunming, Yunnan, China

Countries

China

Other Identifiers

KMHD-01

Identifier Type: -

Identifier Source: org_study_id