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Recruiting NCT05404906

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

Phase II / Phase III Interventional Acute Myeloid Leukemia (AML) in Remission

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: Azacitidine, Venetoclax, Supportive care.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia (AML) in Remission. Basic parameters: 18 years — 64 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

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

Overview

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.

Interventions

  • Drug Azacitidine
    Given SC
  • Drug Venetoclax
    Given PO
  • Other Supportive care
    Patients will receive disease monitoring and supportive care for any complication.

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD) Negative Conversion [Time frame: Measured From Baseline to approximately 3 years]
  • Complete remission duration (CRd) [Time frame: From date of CR/CRi to approximately 3 years]
  • Overall Survival (OS) [Time frame: Time from treatment to death from any cause, up to approximately 3 years]
  • 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]
  • Incidence of adverse events [Time frame: Time from treatment to approximately 3 years]

Eligibility criteria

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.

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • First Affiliated Hospital of Soochow University — Suzhou
  • The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology — Suzhou

Identifiers

NCT: NCT05404906 · SZ-AML124

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗