Trial Title:
Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
NCT ID:
NCT06084819
Condition:
Relapsed/Refractory Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cytarabine
Azacitidine
Venetoclax
Aclacinomycins
Lenograstim
Conditions: Keywords:
Relapsed/Refractory Acute Myeloid Leukemia
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 (75mg/m2/day, days 1 to 7).
2. Cytarabine (75-100mg/m2 q12h, days 1 to 5).
3. Aclacinomycin(20mg/day, days 1,3,5).
4. Chidamide(30mg/day , days 1,4,8,11).
5. Venetoclax (100mg on day 1,200mg on day 2,400mg on days 3-14).
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:
Best-Available Therapy(BAT) Regimen
Description:
1. FLAG regimen:Fludarabine(30mg/m2,days 1-5)+Cytarabine (1-2g/m2 applied 4h after
fludarabine, days 1 to 5)+Granulocyte colony-stimulating factor(300ug/day,days 0 to
5)
2. CLAG regimen:Cladribine(5mg/2,days 1-5)+Cytarabine (1-2g/m2 applied 4h after
fludarabine, days 1 to 5)+Granulocyte colony-stimulating factor(300ug/day,days 0 to
5)
3. MAE regimen:Mitox(10mg/m2,days 1 to 5)+VP-16(100mg/m2,days 1 to 5)+Cytarabine
(100-150mg/m2,days 1 to 7)
4. DCAG regimen:Decitabine(20mg/m2,days 1 to 5)+Aclacinomycin(20mg/day on days
1,3,5)+Cytarabine (100mg q12h,days 1 to 5)+Granulocyte colony-stimulating factor(300
ug/day,day 0 until agranulocytosi recovery)
5. HAA regimen:HHT(2mg/m2,days 1 to 7)+Aclacinomycin(20mg/day,days 1 to 7) and
Cytarabine (100-200 mg/m2, days 1 to 5);
6. HAD regimen:HHT(2mg/m2,days 1 to 7)+Daunorubicin(45mg/m2/day,days 1 to 3)+Cytarabine
(100-200 mg/m2,days 1 to 5).
Arm group label:
Best-Available Therapy(BAT) Regimen
Other name:
FLAG/CLAG/MAE/DCAG/HAA/HAD Regimen
Summary:
The purpose of this study is to compare the efficacy and safety of venetoclax combined
with CACAG regimen with BAT regimen in the treatment of relapsed/refractory acute myeloid
leukemia.
Detailed description:
Despite advances in therapies for acute myeloid leukemia (AML) in the past decades, some
patients still suffer from relapsed/refractory (R/R) disease, resulting in poor outcomes.
With a median overall survival (OS) of 4-7 months under classic chemotherapy approaches,
it is imperative to explore new treatment options.Accumulating research has demonstrated
the importance of epigenetic modification in the pathogenesis of chemoresistance. Recent
studies have shown that combining venetoclax with hypomethylating agents (HMAs) such as
azacitidine, or low-dose cytarabine (LDAC) improves the response and survival rates in
R/R AML patients. To enhance the response rate, we designed a regimen that combines
chidamide, azacitidine, cytarabine, aclarubicin, and G-CSF with venetoclax (CACAG+VEN
regimen) for the treatment of patients with R/R AML. In this study, we intend to compare
the efficacy and safety of venetoclax combined with the CACAG regimen with Best-Available
Therapy(BAT) regimen in the treatment of relapsed/refractory 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 to 75 years,no gender limitation.
- Patients with R/R AML, diagnosed in accordance with the 2021 edition of the CMA
criteria
- 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/NCT06084819
