A Prospective, Two-arm, Multi-center Clinical Study of the Efficacy and Safety of Tretinoin Capsules Combined With Azacitidine and Venetoclax in Treatment Naïve Participants With Acute Myeloid Leukemia
Phase: NA
Conditions: AML, Adult
Sponsor: The First Affiliated Hospital of Soochow University

Official Title 
Study of Tretinoin Capsules in Combination With 
Azacitidine and Venetoclax in Treatment Naïve 
Participants With Acute Myeloid Leukemia 
NCT Number NA  
Document Time February 2, 2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Subject Number: Version Number: 1.0  
Study of Tretinoin Capsules in Combination With 
Azacitidine and Venetoclax in Treatment Naïve 
Participants With Acute Myeloid Leukemia 
I.Research protocol 
The experimental group will receive a combination therapy of all-trans retinoic acid (ATRA), 
azacitidine, and venetoclax, while the control group will receive a combination therapy of 
daunorubicin and cytarabine. All patients need to complete two cycle of induction therapy. After 
two cycle of induction therapy the patients who are willing to receive bone marrow transplantation 
can be treated with a bone marrow transplant, and the patients who refuse the bone marrow 
transplantation can treated with consolidation therapy followed by connective maintenance 
therapy.  
(1) Experimental group:Inductive therapy: AZA 75mg/m² per day for days 1-7 and venetoclax 
100mg orally for day 1 , 200mg orally for day 2, 300mg orally for day3-5, 400mg orally for day 6-
9,ATRA 45mg/m² for day 11-28,every 28 days for up to 2 cycles or progression; Consolidate 
therapy:AZA 75mg/m² per day for days 1-7 and venetoclax 100mg orally for day 1 , 200mg 
orally for day 2, 300mg orally for day3-5, 400mg orally for day6-9,ATRA 45mg/m² for day 11-
28,every 28 days for up to 2 cycles or progression; Maintenance therapy:ATRA 45mg/m2 for d1-
21 every 28 days,AZA 70mg/m² per day for days 1-7.Once per month for 4 doses, followed by 
once every 3 months, commencing concurrently with azacitidine untill progression; 
(2) Control group:Inductive therapy: Daunorubicin: 60 mg/m2 for day 1-3, Cytarabine: 100 mg/m2 
for day 1-7,every 28 days for up to 2 cycles or progression; Consolidate therapy:A chemotherapy 
regimen with intermediate-dose cytarabine alone or in combination with anthracycline drugs 
(cytarabine 1.5-2g/m2),every 28 days for up to 2 cycles or progression; Maintenance therapy:AZA 
70mg/m² per day for days 1-7.Once per month for 4 doses, followed by once every 3 months, 
commencing concurrently with azacitidine untill progression; 
 
II. Study procedure and time frame 
The efficacy was assessed within 2 years after treatment, and the assessment indexes included 
composite complete response (CRc), the overall response rate (ORR), MRD, rate of transfusion 
independence and overall survival (OS).  
 
III. Conventional treatment plan outside the study 
Participants may utilize other "3+7" regimens combining mitoxantrone/idarubicin with cytarabine, 
or the FLAG-IDA protocol, in addition to this study. Symptoms may be alleviated and the disease 
may respond to treatment. However, this is often accompanied by side effects such as nausea, 
vomiting, hair loss, and oral mucositis, which suppress bone marrow function leading to a 
decrease in white blood cells, red blood cells, and platelets, increasing the risks of infection, 
anemia, and bleeding. There is also potential for damage to organs such as the liver, kidneys, and 
heart. Additionally, there may be the development of resistance to certain chemotherapy drugs, 

leading to a decrease in therapeutic efficacy or disease non-response. It is not guaranteed to be 
more effective than existing treatments. 
  
IV. Clinical data processing and confidentiality of clinical research data 
The information and data recorded by the subjects participating in the study will be kept strictly 
confidential and will not be disclosed, and if the study results are published, the subjects identity 
information will also be kept confidential. At the same time, conduct regular patient follow - up, 
data detection, and complete data entry. After all the data have been collected, use SPSS 23.0 
statistical software for data processing and analysis.