VA vs DA for Newly Diagnosed Hig-risk AML

Last updated: April 7, 2024
Sponsor: The First Affiliated Hospital of Soochow University
Overall Status: Active - Recruiting

Phase

2/3

Condition

Acute Myeloid Leukemia

Leukemia

Platelet Disorders

Treatment

Venetoclax Oral Tablet

Daunorubicin

Clinical Study ID

NCT05939180
Victor AML-1
  • Ages 18-64
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. Patients with acute promyeloid leukemia.
  2. AML with central nervous system infiltration.
  3. Patients diagnosed with myeloid sarcoma.
  4. Patients have AML secondary to MDS and previously been treated with hypomethylatingagents.
  5. Patients with active infection, which is considered as uncontrollable by theinvestigator.
  6. Patients with active hepatitis B, hepatitis C and HIV infection.
  7. Patients with heart failure (grade 3-4);
  8. Patients who are pregnant or breastfeeding.
  9. Patients who refused to be enrolled in the study. Patients who are considered asineligible for the enrollment by the investigators.

Study Design

Total Participants: 116
Treatment Group(s): 2
Primary Treatment: Venetoclax Oral Tablet
Phase: 2/3
Study Start date:
April 01, 2024
Estimated Completion Date:
October 01, 2027

Study Description

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. Newly diagnosed AML patients with adverse risk features according to 2022 European Leukemia Net risk stratification will be enrolled. In the study, a novel second generation targeted sequencing panel for the fast screening of adverse mutations with 72-hours after the bone marrow samples will be utilized. Randomized participants will receive induction treatment . Participants will be 1:1 randomly assigned to the VA and DA groups. VA regimen comprises of azacytidine, 75mg/m2, subcutaneously, on days 1-7; venetoclax, orally, once a day, 100mg, d1; 200mg, d2; 400mg, days 3-28. DA regimen comprises of daunorubicin (60mg/m2) on days 1-3, intraveneously injection, and cytarabine (100mg/m2) on days 1-7, intraveneously injection, for 1 cycle. 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.

Connect with a study center

  • Ethical Committee of the First Affliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

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

    Suzhou, Jiangsu 215000
    China

    Active - Recruiting

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