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NCT Number: NCT07539818

Azacitidine + Venetoclax VS Azacitidineas Maintenance Therapy in AML

This is a prospective, multicenter, randomized, open-label, phase III trial evaluating the efficacy and safety of azacitidine plus venetoclax versus azacitidine alone as maintenance therapy in patients with acute myeloid leukemia (AML) who have achieved first complete remission (CR) or CR with incomplete count recovery (CRi) after induction and consolidation. Eligible patients aged 14 to 74 years are randomized 1:1 to receive either azacitidine 50 mg/m²/day on days 1-5 every 6 weeks for up to 12 cycles, or the same azacitidine regimen combined with venetoclax 400 mg on days 1-7 per cycle. The primary endpoint is disease-free survival (DFS). Secondary endpoints include overall survival (OS), relapse-free survival (RFS), cumulative incidence of relapse (CIR), minimal residual disease (MRD) conversion rate, and safety. A total of 788 patients are planned with stratification by prior venetoclax exposure and MRD status.

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Key information

Conditions

AML

Age range

14 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of AML per WHO 2022 or ICC criteria, or MDS/AML (10-20% blasts) per ICC
  • Age ≥14 and <75 years
  • ECOG performance status 0-2
  • First complete remission (CR) or CR with incomplete count recovery (CRi) after induction and consolidation
  • Received at least 2 cycles of intermediate- or high-dose cytarabine (cumulative dose ≥6 g/m² per cycle)
  • Time from first CR/CRi to enrollment ≤10 months, and time from last treatment to enrollment ≤3 months
  • MRD-negative or low-level MRD detectable; MRD-positive patients are excluded
  • Signed informed consent

Exclusion criteria

  • Acute promyelocytic leukemia with PML-RARA
  • AML with BCR-ABL
  • Active central nervous system involvement
  • Prior allogeneic hematopoietic stem cell transplantation
  • Planned allogeneic HSCT within 6 months
  • Deemed unsuitable by investigator

Treatment and study plan

Venetoclax

Drug

400 mg on days 1-7, every 6 weeks for 12 cycles

Azacitidine

Drug

50 mg/m²/day on days 1-5, every 6 weeks for 12 cycles

Primary outcomes

  1. Disease-Free Survival

    Time frame: up to 2 years

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: up to 2 years

  2. Relapse-Free Survival (RFS)

    Time frame: up to 2 years

  3. Complete Remission Duration (CRd)

    Time frame: up to 1 year

  4. DFS-MRD

    Time frame: Up to 2 years

  5. RFS-MRD

    Time frame: Up to 2 years

  6. Cumulative Incidence of Relapse (CIR)

    Time frame: Up to 5 years

  7. CIR-MRD

    Time frame: up to 5 years

  8. MRD Negativity Conversion Rate

    Time frame: up to 5 years

Study contacts

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

Hui Wei, MD

CONTACT

[email protected]

13132507161

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

A Study of Azacitidine With or Without Venetoclax as Maintenance Therapy in Acute Myeloid Leukemia

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Apr 20, 2026
Registry last updated
Apr 20, 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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