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Recruiting NCT06394011

Study of VA Combined With HAAG Regimen in Newly Diagnosed Intermediate and High-risk AML Patients

Phase II Interventional Intermediate Risk Acute Myeloid Leukemia High Risk 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, azacitidine and HAAG regimen.
Who it may be relevant to
Registry conditions: Intermediate Risk Acute Myeloid Leukemia, High Risk Acute Myeloid Leukemia. Basic parameters: 18 years — 65 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 →

Unsure about the terms? Read our patient guide →

Official title

A Single-center, Single-arm, Prospective Clinical Study on the Efficacy and Safety of Venetoclax and Azacitidine Combined With HAAG in the Induction Treatment of Intermediate and High-risk Acute Myeloid Leukemia

Overview

The purpose of this study is to evaluate the efficacy and safety of VA combined with HAAG in the induction treatment of newly diagnosed acute myeloid leukemia.

Detailed description

This is a single-center, single-arm, prospective clinical study in newly diagnosed intermediate and high-risk AML patients. The patients will receive venetoclax, azacitidine combined with HAAG regimen in the induction treatment.

Interventions

  • Drug venetoclax, azacitidine and HAAG regimen
    Venetoclax:100mg, qd, d1;200mg, qd, d2;400 mg, qd, d3\~10, per os; Azacitidine:75mg/m2/d, d1\~7, subcutaneous injection; Homoharringtonine:1mg/d, d4\~10, intravenous infusion; Aclarubicin:10mg/d, d4\~7, intravenous infusion; Cytarabine:10mg/m2,q12h,d4\~10, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300μg/d (when WBC counts are less than 20×10\^9/L ),subcutaneous injection;

Primary outcome measures

  • Composite complete response rate (CRc; CR+CRi) [Time frame: Day 28-35 of induction course]
Secondary outcome measures (4)
  • Partial remission (PR) [Time frame: Day 28-35 of induction course]
  • Number of adverse events [Time frame: 2 years]
  • Relapse-free survival (RFS) [Time frame: 3 years]
  • Overall survival (OS) [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • Newly diagnosed intermediate and high-risk AML according to the WHO (2022) classification of acute myeloid leukemia (non-APL).
  • Age 18-65.
  • ECOG score: 0-2.
  • No history of previous chemotherapy or target therapy.
  • Serum total bilirubin <= 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) <= 1.5 times ULN, aspartate aminotransferase (AST) <=1.5 times ULN;
  • Creatinine clearance rate >=30 mL/min;
  • Serum lipase <= 1.5 times ULN, amylase <= 1.5 times ULN;
  • Capable to understand and willing to participate in this study, signed the informed consent form.

Exclusion criteria

  • AML transformed with chronic myelogenous leukemia.
  • Acute promyelocytic leukemia (type M3).
  • Patients with a second malignancy requiring treatment.
  • Patients with uncontrolled active infection.
  • Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
  • Patients with hepatic and renal inadequacy: total serum bilirubin >=2.0 mg/dl, AST >=3 times ULN, serum creatinine clearance (Ccr) <50 ml / min.
  • Patients with arterial oxygen saturation (SpO 2) was <95%.
  • Patients with HIV infection.
  • Patients with active hepatitis B or hepatitis C infection.
  • Patients with other commodities that the investigators considered not suitable for the enrollment.

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT06394011 · VA+HAAG

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗