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

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · May 31, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring whether a combination of two medications, azacitidine and venetoclax, can help prevent relapse in younger adults who have recently achieved remission from a type of blood cancer called acute myeloid leukemia (AML). The goal is to see if this treatment can improve the time these patients stay in remission after their initial treatment. The trial is currently recruiting participants aged 18 to 64 who have a specific type of AML that is considered to have a favorable risk and who are not candidates for a stem cell transplant.

To participate, individuals must have completed their initial treatment for AML and be in their first complete remission. They should also have certain health criteria, such as good organ function. Participants will receive the new treatment and will be monitored closely throughout the trial. This study aims to provide more options for patients with AML and better ways to manage their condition after they achieve remission. If you or someone you know might qualify, it could be a chance to be part of important research that could help improve future treatments for this disease.

Gender

ALL

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.