Combining azacitidine and venetoclax for maintenance therapy in younger adults with AML in remission

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of azacitidine combined with venetoclax as maintenance therapy for younger adults aged 18-64 with favorable-risk acute myeloid leukemia (AML) who are in their first complete remission. The goal is to improve relapse-free survival (RFS) after patients have undergone intensive consolidation therapy. Participants must meet specific eligibility criteria, including adequate organ function and not being candidates for allogeneic stem cell transplant. The trial is conducted at the First Affiliated Hospital of Soochow University in China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.
2. Aged 18-64 years.
3. Patients who have received remission induction therapy and 3-4 HiDAC or medium-dose cytarabine-based consolidation and are in their first remission.
4. ECOG performance status of \< or = 3.
5. Adequate organ function as follows:

   1. Serum total bilirubin \< or = to 3 X the Upper Limit of Normal (ULN)
   2. Aspartate Transaminase and alanine transaminase \< or = to 3 x ULN
   3. Ccr（Creatinine Clearance Rate) \> or ＝60 ml/min
   4. Left ventricular ejection fraction \> or ＝50% determined by ultrasound.
6. For females of childbearing age, they should have a negative serum or urine pregnancy test within 10 to 14 days of enrolling.
7. For males of childbearing age, they should take effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment.
8. Ability to understand and sign informed consent.

Exclusion Criteria:

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

Where it's running

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

Study contacts

• Principal investigator: Suning Chen — First Affiliated Hospital of Soochow University
• Study coordinator: Suning Chen
• Email: chensuning@sina.com
• Phone: +86-13814881746

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.