Back to resultsAzacitidine Combined With Venetoclax and ATRA in Newly Diagnosed AML
Primary Purpose
Acute Myeloid Leukemia
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Azacitidine Combined With Venetoclax and ATRA group
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML, Azacitidine, Venetoclax, ATRA
Eligibility Criteria
Inclusion Criteria: Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia. Age ≥ 18years. ECOG score: 0-3. White blood cell count ≤ 25*10^9/L Total bilirubin ≤ 3X the institutional upper limit of normal if attributable to hepatic infiltration by neoplastic disease AST (SGOT) and ALT (SGPT) ≤ 3X the institutional upper limit of normal Creatinine clearance ≥30ml/min Exclusion Criteria: Pregnancy or lactation. Acute promylocytic leukemia or chronic myeloid leukemia in blast crisis. Another malignant disease. Uncontrolled active infection. Left ventricular ejection fraction < 0.3 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification. Active hepatitis B or hepatitis C infection. HIV infection. Other commodities that the investigators considered not suitable for the enrollment.
Sites / Locations
- the First Affiliated Hospital of Soochow UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AVA（Azacitidine Combined With Venetoclax and ATRA）group
Arm Description
(1)Inductive therapy: AZA 75mg/m² per day for days 1-7 and venetoclax 100mg orally for day 2 , 200mg orally for day 3, 300mg orally for day4-6, 400mg orally for day7-10,ATRA 45mg/m² for day 12-28,every 28 days for up to 2 cycles or progression; (2)Consolidate therapy:ATRA 45mg/m2 per day for d1-21 ,AZA 70mg/m² per day for days 1-7, every 28 days for up to 4 cycles or progression; (3) Maintenance therapy:ATRA 45mg/m2 for d1-21 every 28 days,AZA 70mg/m² per day for days 1-7, every 3 month untill progression;
Outcomes
Primary Outcome Measures
Rate of the bone marrow complete response
Rate of the bone marrow complete response after 1 cycle of inductive therapy include Rate of the bone marrow complete response included the rate of the including Complete Remission(CR) and Complete Remission with incomplete hematologic recovery (CRi) after 1 cycle of inductive therapy
Secondary Outcome Measures
Rate of the bone marrow complete response after 2 cycle of inductive therapy
Rate of the bone marrow complete response after 2 cycle of inductive therapy include Rate of the bone marrow complete response included the rate of the including Complete Remission(CR) and Complete Remission with incomplete hematologic recovery (CRi) after 2 cycle of inductive therapy
Minimal Residual Disease (MRD) response
MRD response in bone marrow at the end of 2nd cycle
Overall Survival (OS)
time from randomization to death from any cause
Event Free Survival（EFS）
time from randomization to the relapse ,death or drug is unacceptably toxic
Number of adverse events
adverse events are evaluated with CTCAE V5.0.
Full Information
NCT ID
NCT05654194
First Posted
November 25, 2022
Last Updated
December 8, 2022
Sponsor
The First Affiliated Hospital of Soochow University
1. Study Identification
Unique Protocol Identification Number
NCT05654194
Brief Title
Azacitidine Combined With Venetoclax and ATRA in Newly Diagnosed AML
Official Title
A Single Arm Study to Evaluate the Safety and Efficiency of Azacitidine (AZA) Combination With Venetoclax and ATRA in Patients With Newly Diagnosed Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2025 (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
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This is a single arm study to evaluate the safety and efficiency of azacitidine (AZA) combination with venetoclax and ATRA in Patients With Newly diagnosed acute myeloid leukemia. Azacitidine, venetoclax and ATRA, may stop the growth of cancer cells, either by demethylation, by promoting cells differentiation or by killing the cells.
Detailed Description
This study include newly diagnosed AML patients who will accept the therapy with AZA combined with venetoclax and ATRA: (1)Inductive therapy: AZA 75mg/m² per day for days 1-7 and venetoclax 100mg orally for day 2 , 200mg orally for day 3, 300mg orally for day4-6, 400mg orally for day7-10,ATRA 45mg/m² for day 12-28, every 28 days for up to 2 cycles or progression; (2)Consolidate therapy:ATRA 45mg/m2 per day for d1-21 ,AZA 70mg/m² per day for days 1-7, every 28 days for up to 4 cycles or progression; (3) Maintenance therapy:ATRA 45mg/m2 for d1-21 every 28 days,AZA 70mg/m² per day for days 1-7, every 3 month till progression;
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AML, Azacitidine, Venetoclax, ATRA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AVA（Azacitidine Combined With Venetoclax and ATRA）group
Arm Type
Experimental
Arm Description
(1)Inductive therapy: AZA 75mg/m² per day for days 1-7 and venetoclax 100mg orally for day 2 , 200mg orally for day 3, 300mg orally for day4-6, 400mg orally for day7-10,ATRA 45mg/m² for day 12-28,every 28 days for up to 2 cycles or progression; (2)Consolidate therapy:ATRA 45mg/m2 per day for d1-21 ,AZA 70mg/m² per day for days 1-7, every 28 days for up to 4 cycles or progression; (3) Maintenance therapy:ATRA 45mg/m2 for d1-21 every 28 days,AZA 70mg/m² per day for days 1-7, every 3 month untill progression;
Intervention Type
Drug
Intervention Name(s)
Azacitidine Combined With Venetoclax and ATRA group
Other Intervention Name(s)
AVA group
Intervention Description
AZA 75mg/m² per day for days 1-7 and venetoclax 100mg orally for day 2 , 200mg orally for day 3, 300mg orally for day4-6, 400mg orally for day7-10,ATRA 45mg/m² for day 12-28,every 28 days for up to 2 cycles as the inductive therapy.ATRA 45mg/m2 per day for d1-21 ,AZA 70mg/m² per day for days 1-7, every 28 days for up to 4 cycles for consolidate therapy.ATRA 45mg/m2 for d1-21 every 28 days,AZA 70mg/m² per day for days 1-7, every 3 month for Maintenance therapy
Primary Outcome Measure Information:
Title
Rate of the bone marrow complete response
Description
Rate of the bone marrow complete response after 1 cycle of inductive therapy include Rate of the bone marrow complete response included the rate of the including Complete Remission(CR) and Complete Remission with incomplete hematologic recovery (CRi) after 1 cycle of inductive therapy
Time Frame
after completion of one induction courses (1st Induction Course is 28 days) and before starting of the 2nd cycle
Secondary Outcome Measure Information:
Title
Rate of the bone marrow complete response after 2 cycle of inductive therapy
Description
Rate of the bone marrow complete response after 2 cycle of inductive therapy include Rate of the bone marrow complete response included the rate of the including Complete Remission(CR) and Complete Remission with incomplete hematologic recovery (CRi) after 2 cycle of inductive therapy
Time Frame
after completion of two induction courses (1st Induction Course is 28 days) and before starting of the 1st Consolidation cycle
Title
Minimal Residual Disease (MRD) response
Description
MRD response in bone marrow at the end of 2nd cycle
Time Frame
after completion of two induction courses (one Course is 28 days) and before starting of the 1st Consolidation cycle
Title
Overall Survival (OS)
Description
time from randomization to death from any cause
Time Frame
2 years
Title
Event Free Survival（EFS）
Description
time from randomization to the relapse ,death or drug is unacceptably toxic
Time Frame
2 years
Title
Number of adverse events
Description
adverse events are evaluated with CTCAE V5.0.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.
Age ≥ 18years.
ECOG score: 0-3.
White blood cell count ≤ 25*10^9/L
Total bilirubin ≤ 3X the institutional upper limit of normal if attributable to hepatic infiltration by neoplastic disease
AST (SGOT) and ALT (SGPT) ≤ 3X the institutional upper limit of normal
Creatinine clearance ≥30ml/min
Exclusion Criteria:
Pregnancy or lactation.
Acute promylocytic leukemia or chronic myeloid leukemia in blast crisis.
Another malignant disease.
Uncontrolled active infection.
Left ventricular ejection fraction < 0.3 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
Active hepatitis B or hepatitis C infection.
HIV infection.
Other commodities that the investigators considered not suitable for the enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Han, PhD
Phone
8613901551669
Email
hanyue@suda.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Chengyuan Gu, MD
Phone
8618068016508
Email
guchengyuan@suda.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yue Han, PhD
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
City
Suzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengyuan Gu, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Azacitidine Combined With Venetoclax and ATRA in Newly Diagnosed AML
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