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Trial Title:
Venetoclax Combined With Azacitidine and CAG in Refractory/Relapse Acute Myeloid Leukemia
NCT ID:
NCT05807347
Condition:
Refractory/Relapse Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Recurrence
Cytarabine
Azacitidine
Venetoclax
Aclacinomycins
Lenograstim
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Open lable
Intervention:
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
VA regimen Drug: Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21); Drug:
Azacitidine 75 mg/m2 subcutaneously once daily on days 1-7. CAG regimen Drug: Cytarabine
10mg/m2 subcutaneously q12h on days 1-7 Drug: Aclacinomycin 12-14mg/m2 on days 1,3,5,7
Drug: Granulocyte colony-stimulating factor 5ug/kg on days 0-8, discontinue if WBC
>20×109/L
Arm group label:
VACAG（Venetoclax Combined with Azacitidine and CAG）regimen
Other name:
Azacitidine
Other name:
Cytarabine
Other name:
Aclacinomycin
Other name:
Granulocyte colony-stimulating factor
Summary:
This study aims to assess the therapeutic efficacy and safety of venetoclax in
combination with azacitidine and CAG as induction regimen in Patients with
Refreactory/Relapse Acute Myeloid Leukemia.
Detailed description:
This is an open-label, multicenter, phase II clinical trial to assess the therapeutic
efficacy and safety of venetoclax in combination with azacitidine (VA) and CAG (G-CSF
priming, low dose cytarabine, and aclarubicin) as induction regimen in Patients with
Refreactory/Relapse Acute Myeloid Leukemia(AML).
Previous studies have shown that venetoclax plus intense chemotherapy represent promising
efficacy in de novo AML patients with high complete remission rates and good tolerance.
Our preliminary results suggest that venetoclax in combination with azacitidine and CAG
are well tolerated and effective for patients who were diagnosed with refreactory/relapse
AML. Thus, this phase II clinical trial is going to further explore its efficacy and
safety. It is expected that about 42 patients will take part in this trial.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients ≥ 18 years old and ≤ 65 years old
2. Refractory/Relapse AML patients according to 2016 World Health Organization (WHO)
classification;
3. Eastern Cooperative Oncology Group (ECOG) Performance status score less than 3;
4. Liver function: Total bilirubin ≦2 upper limit of normal (ULN); aspartate
aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN
5. Renal function：Ccr（Creatinine Clearance Rate） ≧30 ml/min; Scr (serum creatinine) ≦2
ULN
6. Heart function: left ventricular ejection fraction ≧45%
7. Patients must participate in this clinical trial voluntarily and sign an informed
consent form.
Exclusion Criteria:
1. Other diseases；
2. AML with central nervous system (CNS) infiltration；
3. Patients have received prior CAG or VA regimen before；
4. Patients with a life expectancy <3 months
5. Patients with uncontrolled active infection;
6. HIV infection;
7. Evidence of other clinically significant uncontrolled condition(s) including, but
not limited to: a) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring
treatment. b) An active second cancer that requires treatment within 6 months of
study entry
8. Female who are pregnant, breast feeding or childbearing potential.
9. Patients deemed unsuitable for enrollment by the investigator;
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Hematology,920th Hospital of Joint Logistic Support Force of People's Liberation
Address:
City:
Kunming
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Liu, Professor
Phone:
0871-64774206
Email:
Wangsanbin2022@126.com
Start date:
February 1, 2023
Completion date:
February 1, 2026
Lead sponsor:
Agency:
Hematology department of the 920th hospital
Agency class:
Other
Source:
Hematology department of the 920th hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05807347
