Clinical trial NCT06451861: Randomized Study of ABC-14 Regimen Compared With "3+7" Standard Induction Therapy or AB-14 for ND AML
Official title: Randomized Study of ABC-14 Regimen ( AZA, Venetoclax and Chidamide) Compared With "3+7" Standard Induction Therapy or AB-14 (Venetoclax Combined With Azacitidine) for Newly Diagnosed Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: ABC-14 regimen
"3+7" regimen
AB-14 regimen
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy and safty of ABC-14 regimen with the traditional "3+7" regimen or AB-14 regimen in the treatment of newly diagnosed acute myeloid leukaemia

Detailed description: Acute myeloid leukemia (AML) is a clonal malignant blood disease with genetic heterogeneity and originated from hematopoietic stem progenitor cells.In the past 50 years, the "3+7" induction regimen represented by cytotoxic drugs (including anthracyclines/anthraquinones combined with cytarabine) has remained the standard induction regimen for newly diagnosed AML patients with intensive chemotherapy. In AML patients \<60 years old, the "3+7" regimen induces a complete response rate of 60% to 80%, but the treatment-related mortality is as high as 13%, and more than half of the patients face the threat of relapse, and the 5-year overall survival rate is about 35% to 40%.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with AML (the diagnostic criteria refer to WHO2022 standard, non-APL), and have not received systemic anti-leukemia therapy (except hydroxyurea, low-dose cytarabine and other tumor reduction pretreatments);
2. Age ≥18 years old;
3. ECOG≤4;
4. The fertile woman agrees to use effective contraception during the treatment period and up to 3 months after the end of the treatment; Sign the informed consent form.

Exclusion Criteria:

1. Known history of allergy to the investigational drug;
2. Resistance to azacytidine, azacitidine, Venetoclax;
3. Inability to take oral medication;
4. Combined with uncontrolled active infections (including bacterial, fungal or viral infections);
5. Combined with uncontrolled major organ dysfunction: cardiac insufficiency, decompensated liver insufficiency, moderate/severe renal insufficiency, etc.;
6. Participating in other clinical studies that affect the main purpose of this study; Patients deemed unsuitable for participation in this study.

Primary outcomes:
measure: Composite complete remission (CRc)
timeFrame: 2 months
Secondary outcomes:
measure: the rate of MRD turn negative
timeFrame: 6 months
measure: DoR
timeFrame: 2 year
measure: RFS
timeFrame: 1 year
measure: OS
timeFrame: 1 year
measure: AE
timeFrame: Throughout the study until the end, up to 2 years
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Dongguan General Hosptial
state: Guangdong
city: Foshan
country: China
facility: Foshan First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangdong Pharmaceutical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen second people's Hospital
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Zhuhai
country: China
facility: Zhuhai General Hosptial
state: Guangdong
city: Haikou
country: China
facility: Hainan General Hosptial
state: Hainan
Study officials:
affiliation: Guangdong Provincial People Hosptial
name: Jianyu Weng
role: PRINCIPAL_INVESTIGATOR
References: