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

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

This study is testing if combining two medications, azacitidine and venetoclax, can help younger adults with acute myeloid leukemia stay in remission longer after their initial treatment.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Locations: 2 sites (Suzhou, Jiangsu and 1 other locations)
• Trial ID: NCT05404906 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are younger adults aged 18-64 with favorable-risk AML in their first complete remission.

Not a fit: Patients who are not in remission or those who are immediate candidates for allogeneic stem cell transplant may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly extend the time patients remain free from relapse of AML.

How similar studies have performed: While this approach is being evaluated in this trial, similar combinations have shown promise in other studies, indicating potential for success.

Eligibility criteria

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 this trial is running

Suzhou, Jiangsu and 1 other locations

• 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

Conditions Acute Myeloid Leukemia in Remission