Recruiting NCT05939180

VA vs DA for Newly Diagnosed Hig-risk AML

Phase II / Phase III Interventional Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Venetoclax Oral Tablet, Daunorubicin.
Who it may be relevant to: Registry conditions: Acute Myeloid Leukemia. Basic parameters: 18 years — 64 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Study of the Efficacy and Safety of Venetoclax Plus Azacytidine Versus Daunorubicin Plus Cytarabine in Adult Acute Myeloid Leukemia (AML) Patients With Adverse Risk Features

Overview

Detailed 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.

Interventions

Drug Venetoclax Oral Tablet
VA regimen: azacytidine, 75mg/m2, subcutaneously, on days 1-7; venetoclax, orally, once a day, 100mg, d1; 200mg, d2; 400mg, days 3-28.
Drug Daunorubicin
DA regimen: daunorubicin (60mg/m2) on days 1-3, intraveneously injection, and cytarabine (100mg/m2) on days 1-7, intraveneously injection, for 1 cycle.

Primary outcome measures

Composite complete remission (CRc) after one course of induction therapy [Time frame: From randomization to the end of the first course of induction therapy (within 28 days)]

Secondary outcome measures (6)

DOR: duration of remission [Time frame: 2 years]
EFS：event-free survival [Time frame: 2 years]
OS: overall survival [Time frame: 2 years]
Volume of infused blood products [Time frame: Within 60 days after randomization]
AE [Time frame: Within 60 days after randomization]
Composite complete remission (CRc) after two courses of induction therapy [Time frame: From randomization to the end one and two courses of induction therapy (within 60 days)]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

China · 2 centers

The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology — Suzhou
Ethical Committee of the First Affliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT05939180 · Victor AML-1

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗