Back to resultsVA vs DA for ND Hig-risk AML
Primary Purpose
Acute Myeloid Leukemia
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Venetoclax Oral Tablet
Daunorubicin
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Adverse risk, newly diagnosed, induction therapy
Eligibility Criteria
Inclusion Criteria: Gender: female or male. Age:18-64 years old. Patients with newly diagnosed AML according to the WHO 2022 classification. AML patients with adverse risk features according to the 2022 European Leukemia Net risk stratification. Untreated AML (hydroxyurea, and low dose cytarabine with cummulative dose <1.0g are permitted). ECOG: 0-2. 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) . Adequate Renal function: Ccr (Creatinine Clearance Rate) ≥30 ml/min. Be able to understand and be willing to participate in the study. Be able to provide written informed consent. Exclusion Criteria: Patients with acute promyeloid leukemia. AML with central nervous system infiltration. Patients diagnosed with myeloid sarcoma. Patients have AML secondary to MDS and previously been treated with hypomethylating agents. Patients with active infection, which is considered as uncontrollable by the investigator. Patients with active hepatitis B, hepatitis C and HIV infection. Patients with heart failure (grade 3-4); Patients who are pregnant or breastfeeding. Patients who refused to be enrolled in the study. Patients who are considered as ineligible for the enrollment by the investigators.
Sites / Locations
- The First Affiliated Hospital of Soochow University, Jiangsu Institute of HematologyRecruiting
- Ethical Committee of the First Affliated Hospital of Soochow UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VA regimen
DA regimen
Arm Description
VA regimen: azacytidine and venetoclax
DA regimen: daunorubicin and cytarabine
Outcomes
Primary Outcome Measures
Overall response rate (ORR)
Rates of complete remission/complete remission with incomplete count recovery/morphologic leukemia free state.
Secondary Outcome Measures
DOR: duration of remission
Time between the first remission and relapse
EFS：event-free survival
time from the date of enrollment to treatment failure, relapse, death from any cause or the last follow-up
OS: overall survival
time from the date of enrollment to death from any cause or the last follow-up
Volume of infused blood products
The volume of infused blood products during the induction treatment.
AE
Adverse events during the induction treatment.
Full Information
NCT ID
NCT05939180
First Posted
July 3, 2023
Last Updated
July 3, 2023
Sponsor
The First Affiliated Hospital of Soochow University
1. Study Identification
Unique Protocol Identification Number
NCT05939180
Brief Title
VA vs DA for ND Hig-risk AML
Official Title
Study of the Efficacy and Safety of Venetoclax Plus Azacytidine Versus Daunorubicin Plus Cytarabine in Adult Acute Myeloid Leukemia (AML) Patients With Adverse Risk Features
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Adverse risk, newly diagnosed, induction therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VA regimen
Arm Type
Experimental
Arm Description
VA regimen: azacytidine and venetoclax
Arm Title
DA regimen
Arm Type
Active Comparator
Arm Description
DA regimen: daunorubicin and cytarabine
Intervention Type
Drug
Intervention Name(s)
Venetoclax Oral Tablet
Other Intervention Name(s)
venetoclax plus azacytidine
Intervention Description
VA regimen: azacytidine, 75mg/m2, subcutaneously, on days 1-7; venetoclax, orally, once a day, 100mg, d1; 200mg, d2; 400mg, days 3-28.
Intervention Type
Drug
Intervention Name(s)
Daunorubicin
Other Intervention Name(s)
daunorubicin plus cytarabine
Intervention 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.
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
Rates of complete remission/complete remission with incomplete count recovery/morphologic leukemia free state.
Time Frame
From randomization to the end of induction therapy (before consolidation therapy, within 60 days)
Secondary Outcome Measure Information:
Title
DOR: duration of remission
Description
Time between the first remission and relapse
Time Frame
2 years
Title
EFS：event-free survival
Description
time from the date of enrollment to treatment failure, relapse, death from any cause or the last follow-up
Time Frame
2 years
Title
OS: overall survival
Description
time from the date of enrollment to death from any cause or the last follow-up
Time Frame
2 years
Title
Volume of infused blood products
Description
The volume of infused blood products during the induction treatment.
Time Frame
Within 60 days after randomization
Title
AE
Description
Adverse events during the induction treatment.
Time Frame
Within 60 days after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gender: female or male.
Age:18-64 years old.
Patients with newly diagnosed AML according to the WHO 2022 classification.
AML patients with adverse risk features according to the 2022 European Leukemia Net risk stratification.
Untreated AML (hydroxyurea, and low dose cytarabine with cummulative dose <1.0g are permitted).
ECOG: 0-2.
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) .
Adequate Renal function: Ccr (Creatinine Clearance Rate) ≥30 ml/min.
Be able to understand and be willing to participate in the study. Be able to provide written informed consent.
Exclusion Criteria:
Patients with acute promyeloid leukemia.
AML with central nervous system infiltration.
Patients diagnosed with myeloid sarcoma.
Patients have AML secondary to MDS and previously been treated with hypomethylating agents.
Patients with active infection, which is considered as uncontrollable by the investigator.
Patients with active hepatitis B, hepatitis C and HIV infection.
Patients with heart failure (grade 3-4);
Patients who are pregnant or breastfeeding.
Patients who refused to be enrolled in the study. Patients who are considered as ineligible for the enrollment by the investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Su-ning Chen
Phone
008613814881746
Email
chensuning@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su-ning Chen
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suning Chen
Phone
13814881746
Email
chensuning@sina.com
Facility Name
Ethical Committee of the First Affliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou-lin Lu
Phone
13914086271
12. IPD Sharing Statement
Plan to Share IPD
No
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VA vs DA for ND Hig-risk AML
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