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
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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);
• Age ≥18 years old;
• ECOG≤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.
Locations
Other Locations
China
Dongguan General Hosptial
RECRUITING
Dongguan
Foshan First People's Hospital
RECRUITING
Foshan
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
The Fifth Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital of Guangdong Pharmaceutical University
RECRUITING
Guangzhou
The First Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital of Jinan University
RECRUITING
Guangzhou
The Second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Hainan General Hosptial
RECRUITING
Haikou
Shenzhen second people's Hospital
RECRUITING
Shenzhen
Affiliated Hospital of Guangdong Medical University
RECRUITING
Zhanjiang
Zhuhai General Hosptial
RECRUITING
Zhuhai
Contact Information
Primary
Jianyu Weng
wengjianyu@gdph.org.cn
020-83827812
Backup
Du Xin
xind@gdph.org.cn
020-83827812
Time Frame
Start Date: 2024-08-21
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 240
Treatments
Experimental: ABC-14 regimen
AZA,Venetoclax,Chidamide
Active_comparator: 3+7 chemotherapy regimen
Daunorubicin/idarubicin/mitoxantrone and cytarabine
Active_comparator: AB-14 regimen
AZA,Venetoclax
Related Therapeutic Areas
Sponsors
Leads: Guangdong Provincial People's Hospital