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Trial Title:
VA vs DA for Newly Diagnosed Hig-risk AML
NCT ID:
NCT05939180
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cytarabine
Azacitidine
Venetoclax
Daunorubicin
Conditions: Keywords:
Adverse risk, newly diagnosed, induction therapy
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Venetoclax Oral Tablet
Description:
VA regimen: azacytidine, 75mg/m2, subcutaneously, on days 1-7; venetoclax, orally, once a
day, 100mg, d1; 200mg, d2; 400mg, days 3-28.
Arm group label:
VA regimen
Other name:
venetoclax plus azacytidine
Intervention type:
Drug
Intervention name:
Daunorubicin
Description:
DA regimen: daunorubicin (60mg/m2) on days 1-3, intraveneously injection, and cytarabine
(100mg/m2) on days 1-7, intraveneously injection, for 1 cycle.
Arm group label:
DA regimen
Other name:
daunorubicin plus cytarabine
Summary:
This is an open-label, multicenter, phase 2b, randomized study aiming to compare the
efficacy and safety of venetoclax plus azacytidine Versus daunorubicin plus cytarabine
(conventional 7+3 regimen) in adult acute myeloid leukemia (AML) patients with adverse
risk featuress. Participants will be 1:1 randomly assigned to the VA and DA groups. Once
remission was achieved, consolidated chemotherapy will be performed and allogeneic
hematopoietic stem cell transplantation is strongly recommended. After completion of the
study intervention, participants will be followed-up every 1 to 2 months for up to 2
years.
Detailed description:
This is an open-label, multicenter, phase 2b, randomized study aiming to compare the
efficacy and safety of venetoclax plus azacytidine Versus daunorubicin plus cytarabine
(conventional 7+3 regimen) in adult acute myeloid leukemia (AML) patients with adverse
risk featuress. Newly diagnosed AML patients with adverse risk features according to 2022
European Leukemia Net risk stratification will be enrolled. In the study, a novel second
generation targeted sequencing panel for the fast screening of adverse mutations with
72-hours after the bone marrow samples will be utilized. Randomized participants will
receive induction treatment . Participants will be 1:1 randomly assigned to the VA and DA
groups. VA regimen comprises of azacytidine, 75mg/m2, subcutaneously, on days 1-7;
venetoclax, orally, once a day, 100mg, d1; 200mg, d2; 400mg, days 3-28. DA regimen
comprises of daunorubicin (60mg/m2) on days 1-3, intraveneously injection, and cytarabine
(100mg/m2) on days 1-7, intraveneously injection, for 1 cycle. Once remission was
achieved, consolidated chemotherapy will be performed and allogeneic hematopoietic stem
cell transplantation is strongly recommended. After completion of the study intervention,
participants will be followed-up every 1 to 2 months for up to 2 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Gender: female or male.
2. Age:18-64 years old.
3. Patients with newly diagnosed AML according to the WHO 2022 classification.
4. AML patients with adverse risk features according to the 2022 European Leukemia Net
risk stratification.
5. Untreated AML (hydroxyurea, and low dose cytarabine with cummulative dose <1.0g are
permitted).
6. ECOG: 0-2.
7. Adequate liver function: Total bilirubin ≤ 1.5×upper limit of normal (ULN);
aspartate aminotransferase (AST) ≤3×ULN (liver infiltration of leukemia: ≤5×ULN);
alanine aminotransferase (ALT)≤3×ULN (liver infiltration of leukemia: ≤5×ULN) .
8. Adequate Renal function: Ccr (Creatinine Clearance Rate) ≥30 ml/min.
9. Be able to understand and be willing to participate in the study. Be able to provide
written informed consent.
Exclusion Criteria:
1. Patients with acute promyeloid leukemia.
2. AML with central nervous system infiltration.
3. Patients diagnosed with myeloid sarcoma.
4. Patients have AML secondary to MDS and previously been treated with hypomethylating
agents.
5. Patients with active infection, which is considered as uncontrollable by the
investigator.
6. Patients with active hepatitis B, hepatitis C and HIV infection.
7. Patients with heart failure (grade 3-4);
8. Patients who are pregnant or breastfeeding.
9. Patients who refused to be enrolled in the study. Patients who are considered as
ineligible for the enrollment by the investigators.
Gender:
All
Minimum age:
18 Years
Maximum age:
64 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Address:
City:
Suzhou
Zip:
215000
Country:
China
Status:
Recruiting
Contact:
Last name:
Suning Chen
Phone:
13814881746
Email:
chensuning@sina.com
Facility:
Name:
Ethical Committee of the First Affliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhou-lin Lu
Phone:
13914086271
Start date:
April 1, 2024
Completion date:
October 1, 2027
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05939180
