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NCT Number: NCT05654194

Azacitidine Combined With Venetoclax and ATRA in Newly Diagnosed AML

This is a single arm study to evaluate the safety and efficiency of azacitidine (AZA) combination with venetoclax and ATRA in Patients With Newly diagnosed acute myeloid leukemia. Azacitidine, venetoclax and ATRA, may stop the growth of cancer cells, either by demethylation, by promoting cells differentiation or by killing the cells.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

the First Affiliated Hospital of Soochow University

Suzhou, China

About this study

This study include newly diagnosed AML patients who will accept the therapy with AZA combined with venetoclax and ATRA: (1)Inductive therapy: AZA 75mg/m² per day for days 1-7 and venetoclax 100mg orally for day 2 , 200mg orally for day 3, 300mg orally for day4-6, 400mg orally for day7-10,ATRA 45mg/m² for day 12-28, every 28 days for up to 2 cycles or progression; (2)Consolidate therapy:ATRA 45mg/m2 per day for d1-21 ,AZA 70mg/m² per day for days 1-7, every 28 days for up to 4 cycles or progression; (3) Maintenance therapy:ATRA 45mg/m2 for d1-21 every 28 days,AZA 70mg/m² per day for days 1-7, every 3 month till progression;

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Azacitidine Combined With Venetoclax and ATRA group

Drug

AZA 75mg/m² per day for days 1-7 and venetoclax 100mg orally for day 2 , 200mg orally for day 3, 300mg orally for day4-6, 400mg orally for day7-10,ATRA 45mg/m² for day 12-28,every 28 days for up to 2 cycles as the inductive therapy.ATRA 45mg/m2 per day for d1-21 ,AZA 70mg/m² per day for days 1-7, every 28 days for up to 4 cycles for consolidate therapy.ATRA 45mg/m2 for d1-21 every 28 days,AZA 70mg/m² per day for days 1-7, every 3 month for Maintenance therapy

Other names: AVA group

Primary outcomes

  1. Rate of the bone marrow complete response

    Time frame: after completion of one induction courses (1st Induction Course is 28 days) and before starting of the 2nd cycle

    Rate of the bone marrow complete response after 1 cycle of inductive therapy include Rate of the bone marrow complete response included the rate of the including Complete Remission(CR) and Complete Remission with incomplete hematologic recovery (CRi) after 1 cycle of inductive therapy

Secondary outcomes

  1. Rate of the bone marrow complete response after 2 cycle of inductive therapy

    Time frame: after completion of two induction courses (1st Induction Course is 28 days) and before starting of the 1st Consolidation cycle

    Rate of the bone marrow complete response after 2 cycle of inductive therapy include Rate of the bone marrow complete response included the rate of the including Complete Remission(CR) and Complete Remission with incomplete hematologic recovery (CRi) after 2 cycle of inductive therapy

  2. Minimal Residual Disease (MRD) response

    Time frame: after completion of two induction courses (one Course is 28 days) and before starting of the 1st Consolidation cycle

    MRD response in bone marrow at the end of 2nd cycle

  3. Overall Survival (OS)

    Time frame: 2 years

    time from randomization to death from any cause

  4. Event Free Survival(EFS)

    Time frame: 2 years

    time from randomization to the relapse ,death or drug is unacceptably toxic

  5. Number of adverse events

    Time frame: 2 years

    adverse events are evaluated with CTCAE V5.0.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Registry information

Official study title

A Single Arm Study to Evaluate the Safety and Efficiency of Azacitidine (AZA) Combination With Venetoclax and ATRA in Patients With Newly Diagnosed Acute Myeloid Leukemia

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Dec 16, 2022
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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