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NCT Number: NCT05404906

AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission

This phase III trial is conducted to evaluate if azacitidine in combination with venetoclax as maintenance therapy improves relapse-free survival (RFS) for younger adults with favorable-risk acute myeloid leukemia (AML) who remained in first complete remission (CR1) following intensive consolidation.

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Key information

Conditions

Acute Myeloid Leukemia (AML) in Remission Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of favorable-risk acute myeloid leukemia (AML) according to revised 2017 European LeukemiaNet genetic risk stratification and are not immediate candidates for allogeneic stem cell transplant.
  • Aged 18-64 years.
  • Patients who have received remission induction therapy and 3-4 HiDAC or medium-dose cytarabine-based consolidation and are in their first remission.
  • ECOG performance status of < or = 3.
  • Adequate organ function as follows:
  • Serum total bilirubin < or = to 3 X the Upper Limit of Normal (ULN)
  • Aspartate Transaminase and alanine transaminase < or = to 3 x ULN
  • Ccr（Creatinine Clearance Rate) > or ＝60 ml/min
  • Left ventricular ejection fraction > or ＝50% determined by ultrasound.
  • For females of childbearing age, they should have a negative serum or urine pregnancy test within 10 to 14 days of enrolling.
  • For males of childbearing age, they should take effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment.
  • Ability to understand and sign informed consent.

Exclusion criteria

  • Acute promyeloid leukemia.
  • Patients with active central nervous system (CNS) leukemia.
  • Previously diagnosed with myelodysplastic syndrome (MDS) or myeloproliferative neoplasm(MPN) and progressed to AML.
  • Patients with other progressive malignancies.
  • Evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled and/or active systemic infection (viral, bacterial or fungal).
  • Patients who have participated in other trials within 30 days before signing the informed consent.
  • Females who are pregnant or lactating or intending to become pregnant during the study.

Treatment and study plan

Azacitidine

Drug

Given SC

Other names: 5-Azacytidine

Venetoclax

Drug

Given PO

Other names: ABT-199, GDC-0199, Venclexta

Supportive Care

Other

Patients will receive disease monitoring and supportive care for any complication.

Primary outcomes

  1. Relapse-free survival (RFS)

    Time frame: From date of complete remission (CR) or complete remission with incomplete count recovery (CRi), to relapse or death from any cause, up to approximately 3 years

    RFS is defined as the number of days from CR/CRi to the date of relapse or the date of death from any cause, whichever comes first.

Secondary outcomes

  1. Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD) Negative Conversion

    Time frame: Measured From Baseline to approximately 3 years

    The MRD conversion rate is defined as the percentage of participants deemed MRD positive (≥ 10^-3) at study initiation who converted to MRD of < 10^-3 in the bone marrow after randomization or initiation of treatment.

  2. Complete remission duration (CRd)

    Time frame: From date of CR/CRi to approximately 3 years

    CRd is defined as time from CR/CRi until date of confirmed relapse

  3. Overall Survival (OS)

    Time frame: Time from treatment to death from any cause, up to approximately 3 years

    OS is defined as the number of days from the date of study treatment to the date of death.

  4. Event free survival (EFS)

    Time frame: Time from treatment to relapse，withdrawal from study due to adverse event and death from any cause, up to approximately 3 years

    EFS is defined as time from the start of study treatment until date of first confirmed relapse, withdrawal from study due to adverse event, or death due to any cause,

  5. Incidence of adverse events

    Time frame: Time from treatment to approximately 3 years

    The NCI Common Toxicity Criteria (CTCAE 5.0) is used to grade adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

Suning Chen

CONTACT

[email protected]

+86-13814881746

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Registry information

Official study title

Randomized, Multicenter, Phase 3 Study of Azacytidine (AZA) + Venetoclax as Maintenance Therapy in Patients With AML in Remissionin Younger Adults With Favorable-risk AML in First Remission After Conventional Chemotherapy

Important dates

Study start
2022
Primary completion
2028
Study completion
2030
First posted
Jun 3, 2022
Registry last updated
Aug 19, 2022

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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