Trial Title:
Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
NCT ID:
NCT06068621
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cytarabine
Azacitidine
Venetoclax
Aclacinomycins
Lenograstim
Conditions: Keywords:
Acute Myeloid Leukemia
First Line Therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor
Description:
1. Azacytidine (75 mg/m2/day, days 1 to 7).
2. Cytarabine (75-100 mg/m2 bid, days 1 to 5).
3. Aclacinomycin(20 mg/day, days 1,3,5).
4. Chidamide (30 mg/day , days 1,4,8,11).
5. Venetoclax (400 mg/day, days 1 to 14,Combined with posaconazole reduced to 100
mg/day,Combined with voriconazole reduced to 200 mg/day ).
6. Granulocyte colony-stimulating factor (300 μg/day, day 0 until agranulocytosis
recovery)
Arm group label:
Venetoclax Combined With CACAG Regimen
Other name:
CACAG+VEN
Intervention type:
Drug
Intervention name:
"3+7"
Description:
IA regimen:
1. Idarubicin (8-10 mg/m2) for 3 days .
2. Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.
DA regimen:
1. Daunorubicin(60 mg/m2) for 3 days.
2. Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.
Arm group label:
"3+7" Regimen
Other name:
IA or DA
Summary:
The purpose of this study is to compare the efficacy and safety of venetoclax combined
with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed
acute myeloid leukemia.
Detailed description:
Despite the availability of hematopoietic stem cell transplantation and the emergence of
many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is
still poor.Over the past years, combination chemotherapy with anthracycline and standard
dose cytarabine (standard "3+7" induction therapy) remains the standard induction. In
order to improve the outcome of patients with de novo AML, we developed a venetoclax
combined with CACAG regimen in the treatment of de novo AML. In this study, we intent to
compare the efficacy and safety of venetoclax combined with CACAG regimen with the
traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patients who are able to understand and willing to sign the informed consent form (ICF).
- All patients should aged 14 to75 years,no gender limitation.
- Patients who are newly diagnosed with AML(no M3).
- Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times
the upper limit of normal;
- Renal function: creatinine ≤the upper limit of normal;
- Patients without any uncontrolled infections , without organ dysfunction or without
severe mental illness;
- The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted
survival ≥ 4 months.
- Patients without severe allergic constitution.
Exclusion Criteria:
- Patients with allergy or contraindication to the study drug;
- Female patients who are pregnant or breast-feeding.
- Patients with a known history of alcohol or drug addiction on the basis that there
could be a higher risk of non-compliance to study treatment;
- Patients with mental illness or other states unable to comply with the protocol;
- Less than 6 weeks after surgical operation of important organs.
- Liver function: ALT and AST>2.5 times the upper limit of normal ,bilirubin> 2 times
the upper limit of normal;Renal function: creatinine >the upper limit of normal;
- The patient is not suitable for this clinical trial (poor compliance, substance
abuse, etc.)
Gender:
All
Minimum age:
14 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese PLA General Hospital
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Contact:
Last name:
Daihong Liu, doctor
Phone:
86-13681171597
Email:
daihongrm@163.com
Contact backup:
Last name:
Liping Dou, doctor
Phone:
86-13681207138
Email:
lipingruirui@163.com
Investigator:
Last name:
Daihong Liu, doctor
Email:
Principal Investigator
Start date:
August 1, 2023
Completion date:
January 31, 2026
Lead sponsor:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Collaborator:
Agency:
The 940th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army
Agency class:
Other
Collaborator:
Agency:
The General Hospital of Western Theater Command
Agency class:
Other
Collaborator:
Agency:
The General Hospital of Northern Theater Command
Agency class:
Other
Collaborator:
Agency:
The 960th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army
Agency class:
Other
Collaborator:
Agency:
Air Force Military Medical University, China
Agency class:
Other
Collaborator:
Agency:
Yantai Yuhuangding Hospital
Agency class:
Other
Collaborator:
Agency:
People's Liberation Army (PLA) Strategic Support Force Characteristic Medical Center
Agency class:
Other
Collaborator:
Agency:
First Hospital of China Medical University
Agency class:
Other
Source:
Chinese PLA General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06068621
