VA vs DA for Newly Diagnosed Hig-risk AML

NCT05939180 | Recruiting Phase 2

• 1 other identifier: Victor AML-1
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open-label, multicenter, phase 2b, randomized study aiming to compare the efficacy and safety of venetoclax plus azacytidine Versus daunorubicin plus cytarabine (conventional 7+3 regimen) in adult acute myeloid leukemia (AML) patients with adverse risk featuress. Participants will be 1:1 randomly assigned to the VA and DA groups. Once remission was achieved, consolidated chemotherapy will be performed and allogeneic hematopoietic stem cell transplantation is strongly recommended. After completion of the study intervention, participants will be followed-up every 1 to 2 months for up to 2 years.

Conditions

Acute Myeloid Leukemia

Keywords

Adverse risk, newly diagnosed, induction therapy

Outcome Measures

Primary Outcomes (1)

• Composite complete remission (CRc) after one course of induction therapy

  Rates of complete remission plus complete remission with incomplete blood cell rates of complete remission or complete remission with incomplete marrow recovery

  From randomization to the end of the first course of induction therapy (within 28 days)

Secondary Outcomes (6)

• DOR: duration of remission

  2 years

• EFS：event-free survival

  2 years

• OS: overall survival

  2 years

• Volume of infused blood products

  Within 60 days after randomization

• AE

  Within 60 days after randomization

Study Arms (2)

VA regimen

EXPERIMENTAL

VA regimen: azacytidine and venetoclax

Drug: Venetoclax Oral Tablet

DA regimen

ACTIVE COMPARATOR

DA regimen: daunorubicin and cytarabine

Drug: Daunorubicin

Interventions

Venetoclax Oral Tablet DRUG

VA regimen: azacytidine, 75mg/m2, subcutaneously, on days 1-7; venetoclax, orally, once a day, 100mg, d1; 200mg, d2; 400mg, days 3-28.

Also known as: venetoclax plus azacytidine

VA regimen

Daunorubicin DRUG

DA regimen: daunorubicin (60mg/m2) on days 1-3, intraveneously injection, and cytarabine (100mg/m2) on days 1-7, intraveneously injection, for 1 cycle.

Also known as: daunorubicin plus cytarabine

DA regimen

Eligibility Criteria

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

You may qualify if:

• Gender: female or male.
• Age:18-64 years old.
• Patients with newly diagnosed AML according to the WHO 2022 classification.
• AML patients with adverse risk features according to the 2022 European Leukemia Net risk stratification.
• Untreated AML (hydroxyurea, and low dose cytarabine with cummulative dose \<1.0g are permitted).
• ECOG: 0-2.
• Adequate liver function: Total bilirubin ≤ 1.5×upper limit of normal (ULN); aspartate aminotransferase (AST) ≤3×ULN (liver infiltration of leukemia: ≤5×ULN); alanine aminotransferase (ALT)≤3×ULN (liver infiltration of leukemia: ≤5×ULN) .
• Adequate Renal function: Ccr (Creatinine Clearance Rate) ≥30 ml/min.
• Be able to understand and be willing to participate in the study. Be able to provide written informed consent.

You may not qualify if:

• Patients with acute promyeloid leukemia.
• AML with central nervous system infiltration.
• Patients diagnosed with myeloid sarcoma.
• Patients have AML secondary to MDS and previously been treated with hypomethylating agents.
• Patients with active infection, which is considered as uncontrollable by the investigator.
• Patients with active hepatitis B, hepatitis C and HIV infection.
• Patients with heart failure (grade 3-4);
• Patients who are pregnant or breastfeeding.
• Patients who refused to be enrolled in the study. Patients who are considered as ineligible for the enrollment by the investigators.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (2)

The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

Suzhou, Jiangsu, 215000, China

RECRUITING

Ethical Committee of the First Affliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; Azacitidine; Daunorubicin; Cytarabine

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; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Arabinonucleosides

Study Officials

• Su-ning Chen

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Su-ning Chen

CONTACT

008613814881746; chensuning@sina.com

Study Design

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

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 11, 2023
• Study Start: April 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 9, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)