Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT06394011

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

Led by The First Affiliated Hospital of Soochow University · Updated on 2024-05-01

60

Participants Needed

1

Research Sites

149 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed intermediate and high-risk AML according to the WHO (2022) classification of acute myeloid leukemia (non-APL).
  • Age 18-65.
  • ECOG score between 0 and 2.
  • No prior chemotherapy or targeted therapy.
  • Serum total bilirubin less than or equal to 2 times the upper limit of normal (ULN).
  • Alanine aminotransferase (ALT) less than or equal to 1.5 times ULN.
  • Aspartate aminotransferase (AST) less than or equal to 1.5 times ULN.
  • Creatinine clearance rate of at least 30 mL/min.
  • Serum lipase less than or equal to 1.5 times ULN.
  • Serum amylase less than or equal to 1.5 times ULN.
  • Able to understand and willing to participate in the study and have signed the informed consent form.
Not Eligible

You will not qualify if you...

  • AML transformed from chronic myelogenous leukemia.
  • Acute promyelocytic leukemia (type M3).
  • Having a second malignancy that requires treatment.
  • Uncontrolled active infection.
  • Left ventricular ejection fraction less than 0.5 or grade III/IV cardiovascular dysfunction.
  • Hepatic and renal inadequacy: total serum bilirubin 2.0 mg/dl or higher, AST 3 times ULN or higher, creatinine clearance less than 50 ml/min.
  • Arterial oxygen saturation below 95%.
  • HIV infection.
  • Active hepatitis B or hepatitis C infection.
  • Other medical conditions deemed unsuitable by investigators.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Actively Recruiting

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Research Team

X

Xiaowen Tang, Ph.D

CONTACT

D

Depei Wu, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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