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

NCT05662956 | Completed Phase 2

• 1 other identifier: KMHD-01
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Myeloid Leukemia

Keywords

Venetoclax; Azacitidine; Granulocyte colony-stimulating factor(G-CSF); Cytarabine; Aclarubicin

Outcome Measures

Primary Outcomes (1)

• CR rate

  At the end of Cycle 1 of induction (each cycle is about 30 days)

Secondary Outcomes (3)

• Adverse Events

  From the first day of induction until the starting day of the next cycle of therapy (up to 60 days）

• Duration of remission

  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)

  After 1 cycle of induction (each cycle is about 30 days)

Other Outcomes (2)

• Overall survival

  From the first day of induction until the date of death from any cause, assessed up to 30 months

• Relapse-free survival

  From the first day of induction until the date of relapse or the date of death from any cause, assessed up to 30 months

Study Arms (1)

Treatment group

EXPERIMENTAL

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.

Drug: Venetoclax in combination with azacitidine and CAG

Interventions

Venetoclax in combination with azacitidine and CAG 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.

Also known as: VA-CAG regimen

Treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years old and ≤ 65 years old
• Newly diagnosed as AML patients according to 2016 World Health Organization (WHO) classification;
• Patients without receiving prior therapy for AML;
• Eastern Cooperative Oncology Group (ECOG) Performance status score less than 3;
• Liver function: Total bilirubin ≦2 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN
• Renal function：Ccr（Creatinine Clearance Rate） ≧30 ml/min; Scr (serum creatinine) ≦2 ULN
• Heart function: left ventricular ejection fraction ≧45%
• Patients must participate in this clinical trial voluntarily and sign an informed consent form.

You may not qualify if:

• Acute promyeloid leukemia；
• AML with central nervous system (CNS) infiltration；
• Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML；
• Patients with a life expectancy \<3 months
• Patients with uncontrolled active infection;
• HIV infection;
• 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.
• Female who are pregnant, breast feeding or childbearing potential.
• Patients deemed unsuitable for enrollment by the investigator.

Sponsors & Collaborators

• Hematology department of the 920th hospital: lead

Study Sites (1)

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

Kunming, Yunnan, 650000, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Sanbin Wang, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: December 23, 2022
• Study Start: December 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: April 30, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

CN (1)