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

Last updated: August 18, 2022
Sponsor: The First Affiliated Hospital of Soochow University
Overall Status: Active - Recruiting

Phase

2/3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05404906
SZ-AML124
  • Ages 18-64
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. Acute promyeloid leukemia.
  2. Patients with active central nervous system (CNS) leukemia.
  3. Previously diagnosed with myelodysplastic syndrome (MDS) or myeloproliferativeneoplasm(MPN) and progressed to AML.
  4. Patients with other progressive malignancies.
  5. Evidence of other clinically significant uncontrolled condition(s) including, but notlimited to uncontrolled and/or active systemic infection (viral, bacterial or fungal).
  6. Patients who have participated in other trials within 30 days before signing theinformed consent.
  7. Females who are pregnant or lactating or intending to become pregnant during thestudy.

Study Design

Total Participants: 124
Study Start date:
June 25, 2022
Estimated Completion Date:
June 30, 2030

Connect with a study center

  • First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

    Suzhou, Jiangsu 215000
    China

    Active - Recruiting

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