Clinical trial NCT05654194: Azacitidine Combined With Venetoclax and ATRA in Newly Diagnosed AML
Official title: A Single Arm Study to Evaluate the Safety and Efficiency of Azacitidine (AZA) Combination With Venetoclax and ATRA in Patients With Newly Diagnosed Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Keywords: AML
Azacitidine
Venetoclax
ATRA
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm study to evaluate the safety and efficiency of azacitidine (AZA) combination with venetoclax and ATRA in Patients With Newly diagnosed acute myeloid leukemia. Azacitidine, venetoclax and ATRA, may stop the growth of cancer cells, either by demethylation, by promoting cells differentiation or by killing the cells.

Detailed description: This study include newly diagnosed AML patients who will accept the therapy with AZA combined with venetoclax and ATRA: (1)Inductive therapy: AZA 75mg/m² per day for days 1-7 and venetoclax 100mg orally for day 2 , 200mg orally for day 3, 300mg orally for day4-6, 400mg orally for day7-10,ATRA 45mg/m² for day 12-28, every 28 days for up to 2 cycles or progression; (2)Consolidate therapy:ATRA 45mg/m2 per day for d1-21 ,AZA 70mg/m² per day for days 1-7, every 28 days for up to 4 cycles or progression; (3) Maintenance therapy:ATRA 45mg/m2 for d1-21 every 28 days,AZA 70mg/m² per day for days 1-7, every 3 month till progression;

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.
* Age ≥ 18years.
* ECOG score: 0-3.
* White blood cell count ≤ 25\*10\^9/L
* Total bilirubin ≤ 3X the institutional upper limit of normal if attributable to hepatic infiltration by neoplastic disease
* AST (SGOT) and ALT (SGPT) ≤ 3X the institutional upper limit of normal
* Creatinine clearance ≥30ml/min

Exclusion Criteria:

* Pregnancy or lactation.
* Acute promylocytic leukemia or chronic myeloid leukemia in blast crisis.
* Another malignant disease.
* Uncontrolled active infection.
* Left ventricular ejection fraction \< 0.3 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
* Active hepatitis B or hepatitis C infection.
* HIV infection.
* Other commodities that the investigators considered not suitable for the enrollment.

Primary outcomes:
measure: Rate of the bone marrow complete response
timeFrame: after completion of one induction courses (1st Induction Course is 28 days) and before starting of the 2nd cycle
Secondary outcomes:
measure: Rate of the bone marrow complete response after 2 cycle of inductive therapy
timeFrame: after completion of two induction courses (1st Induction Course is 28 days) and before starting of the 1st Consolidation cycle
measure: Minimal Residual Disease (MRD) response
timeFrame: after completion of two induction courses (one Course is 28 days) and before starting of the 1st Consolidation cycle
measure: Overall Survival (OS)
timeFrame: 2 years
measure: Event Free Survival（EFS）
timeFrame: 2 years
measure: Number of adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: the First Affiliated Hospital of Soochow University
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Yue Han, PhD
role: PRINCIPAL_INVESTIGATOR
References: