Trial Title:
Randomized Study of ABC-14 Regimen Compared With "3+7" Standard Induction Therapy or AB-14 for ND AML
NCT ID:
NCT06451861
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cytarabine
Azacitidine
Venetoclax
Daunorubicin
Mitoxantrone
Idarubicin
Conditions: Keywords:
ABC-14 regimen
"3+7" regimen
AB-14 regimen
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chidamide
Description:
Induction Therapy
Arm group label:
ABC-14 regimen
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Induction Therapy
Arm group label:
AB-14 regimen
Arm group label:
ABC-14 regimen
Intervention type:
Drug
Intervention name:
azacitidine
Description:
Induction Therapy
Arm group label:
AB-14 regimen
Arm group label:
ABC-14 regimen
Intervention type:
Drug
Intervention name:
Anthracyclines or anthraquinones
Description:
Induction Therapy
Arm group label:
3+7 chemotherapy regimen
Other name:
idarubicin
Other name:
daunorubicin
Other name:
mitoxantrone
Intervention type:
Drug
Intervention name:
cytarabine
Description:
Induction Therapy
Arm group label:
3+7 chemotherapy regimen
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%.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dongguan General Hosptial
Address:
City:
Dongguan
Country:
China
Contact:
Last name:
yirong Jiang
Facility:
Name:
Foshan First People's Hospital
Address:
City:
Foshan
Country:
China
Contact:
Last name:
Ying Zhao
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Contact:
Last name:
Xin Du
Contact backup:
Last name:
Jianyu WENG
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Contact:
Last name:
yang Liang
Facility:
Name:
The Fifth Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Country:
China
Contact:
Last name:
Runhui Zheng
Facility:
Name:
The First Affiliated Hospital of Guangdong Pharmaceutical University
Address:
City:
Guangzhou
Country:
China
Contact:
Last name:
xueyi Pan
Facility:
Name:
The First Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Country:
China
Contact:
Last name:
Zhenqian Huang
Facility:
Name:
The First Affiliated Hospital of Jinan University
Address:
City:
Guangzhou
Country:
China
Contact:
Last name:
hui Zeng
Facility:
Name:
The Second Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Country:
China
Facility:
Name:
Shenzhen second people's Hospital
Address:
City:
Shenzhen
Country:
China
Contact:
Last name:
xin Du
Facility:
Name:
Affiliated Hospital of Guangdong Medical University
Address:
City:
Zhanjiang
Country:
China
Contact:
Last name:
Yuming ZHANG
Facility:
Name:
Zhuhai General Hosptial
Address:
City:
Zhuhai
Country:
China
Contact:
Last name:
xiaoliang Li
Facility:
Name:
Hainan General Hosptial
Address:
City:
Haikou
Country:
China
Contact:
Last name:
Li'e Lin
Start date:
May 31, 2024
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Source:
Guangdong Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06451861
