Venetoclax Combined With Azacitidine and CAG in Refractory/Relapse Acute Myeloid Leukemia

NCT05807347 | Unknown Phase 2 DMC

• 1 other identifier: KM02
• Study Type: interventional
• Target: 42
• 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 as induction regimen in Patients with Refreactory/Relapse Acute Myeloid Leukemia.

Conditions

Refractory/Relapse Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  The overall remission rate (ORR) was defined as the percentage of patients who achieved complete remission (CR), complete remission with incomplete count recovery (CRi), or morphologic leukemia free state (MLFS) per the International Working Group criteria for AML.

  up to 2 cycles from the start of VACAG regimen (each cycle is 28 days)

Secondary Outcomes (5)

• Rate of Minimal Residual Disease (MRD) negativity

  up to 2 years

• Incidence of Treatment-Emergent Adverse Events

  up to 2 years

• Duration of myelosuppression

  up to 2 years

• Leukaemia-free survival

  up to 2 years

• Overall survival

  up to 2 years

Study Arms (1)

VACAG（Venetoclax Combined with Azacitidine and CAG）regimen

EXPERIMENTAL

Participants will receive induction 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.

Drug: Venetoclax

Interventions

Venetoclax DRUG

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 \>20×109/L

Also known as: Azacitidine, Cytarabine, Aclacinomycin, Granulocyte colony-stimulating factor

VACAG（Venetoclax Combined with Azacitidine and CAG）regimen

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
• Refractory/Relapse AML patients according to 2016 World Health Organization (WHO) classification;
• 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:

• Other diseases；
• AML with central nervous system (CNS) infiltration；
• Patients have received prior CAG or VA regimen before；
• 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)

Department of Hematology,920th Hospital of Joint Logistic Support Force of People's Liberation

Kunming, Yunnan, China

RECRUITING

MeSH Terms

Interventions

venetoclax; Azacitidine; Cytarabine; aclacinomycins; Granulocyte Colony-Stimulating Factor

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Arabinonucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

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

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: April 11, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2026
• Last Updated: April 11, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)