Clinical trial NCT05404906: AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Acute Myeloid Leukemia (AML) in Remission
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Relapse-free survival (RFS)
timeFrame: From date of complete remission (CR) or complete remission with incomplete count recovery (CRi), to relapse or death from any cause, up to approximately 3 years
Secondary outcomes:
measure: Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD) Negative Conversion
timeFrame: Measured From Baseline to approximately 3 years
measure: Complete remission duration (CRd)
timeFrame: From date of CR/CRi to approximately 3 years
measure: Overall Survival (OS)
timeFrame: Time from treatment to death from any cause, up to approximately 3 years
measure: Event free survival (EFS)
timeFrame: Time from treatment to relapse，withdrawal from study due to adverse event and death from any cause, up to approximately 3 years
measure: Incidence of adverse events
timeFrame: Time from treatment to approximately 3 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: First Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
state: Jiangsu
Study officials:
affiliation: First Affiliated Hospital of Soochow University
name: Suning Chen
role: PRINCIPAL_INVESTIGATOR
References: