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Search / Trial NCT05654194

Azacitidine Combined With Venetoclax and ATRA in Newly Diagnosed AML

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Dec 8, 2022

Trial Information

Current as of February 05, 2025

Recruiting

Keywords

Aml Azacitidine Venetoclax Atra

ClinConnect Summary

This clinical trial is studying a combination of three medications—azacitidine, venetoclax, and ATRA—to see how well they work together in treating newly diagnosed acute myeloid leukemia (AML), a type of blood cancer. The goal is to find out if this combination can effectively stop the growth of cancer cells and improve patient outcomes. Currently, the trial is looking for participants who are at least 18 years old and have been recently diagnosed with AML. Other important eligibility criteria include having a certain level of white blood cells and liver function, as well as no active infections or other significant health issues.

If you or a family member are eligible and decide to participate, you will receive these medications as part of the study. Researchers will closely monitor your health and the effectiveness of the treatment throughout the trial. This trial is currently recruiting participants, so it's a good opportunity for those looking for new treatment options for AML. Remember, it's essential to discuss any questions or concerns with your healthcare provider before considering participation.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.
  • Age ≥ 18years.
  • ECOG score: 0-3.
  • White blood cell count ≤ 25\*10\^9/L
  • Total bilirubin ≤ 3X the institutional upper limit of normal if attributable to hepatic infiltration by neoplastic disease
  • AST (SGOT) and ALT (SGPT) ≤ 3X the institutional upper limit of normal
  • Creatinine clearance ≥30ml/min
  • Exclusion Criteria:
  • Pregnancy or lactation.
  • Acute promylocytic leukemia or chronic myeloid leukemia in blast crisis.
  • Another malignant disease.
  • Uncontrolled active infection.
  • Left ventricular ejection fraction \< 0.3 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
  • Active hepatitis B or hepatitis C infection.
  • HIV infection.
  • Other commodities that the investigators considered not suitable for the enrollment.

Trial Officials

Yue Han, PhD

Principal Investigator

The First Affiliated Hospital of Soochow University

About The First Affiliated Hospital Of Soochow University

The First Affiliated Hospital of Soochow University is a leading medical institution dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, the hospital leverages its extensive expertise in various medical disciplines to facilitate high-quality, ethically conducted studies that aim to enhance treatment options and improve patient outcomes. With a commitment to collaboration and scientific rigor, the institution plays a pivotal role in contributing to the global body of medical knowledge while ensuring the highest standards of patient care and safety.

Locations

Suzhou, , China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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