Back to resultsOptimizing Induction Chemotherapy Regimens for ND Elderly AML Patients Who Are Eligible for Intense Chemotherapy
Primary Purpose
Acute Myeloid Leukemia
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Different induction chemotherapy regimens
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring elderly, newly diagnosed, fit, induction regimen
Eligibility Criteria
Inclusion Criteria: Able to understand the study and voluntarily sign informed consent. Age: 60~75 years old, gender unlimited. Patients diagnosed with acute myeloid leukemia according to "The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia" who haven't been treated. Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2. Fit for intensive chemotherapy. The function of main organs should meet the following standards before treatment: Kidney: serum creatinine ≤ 2× upper limit of normal range (ULN); Liver: total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5× ULN; Heart: myocardial enzymes ≤ 2× ULN and normal ejection fraction by cardiac color doppler ultrasound Exclusion Criteria: Patients with acute promyelocytic leukemia Patients with RUNX1::RUNX1T1 or CBFB::MYH11 fusion gene Patients with BCR::ABL fusion gene Patients who have received a prior treatment for AML with chemotherapy, hypomethylating agents or venetoclax before. Patients with concurrent malignant tumors requiring treatment Patients with active heart disease defined as one or more of the following: (1) Uncontrolled or symptomatic angina pectoris;(2) A myocardial infarction 6 months before enrolled; (3)Arrhythmia needed medication or with severe clinical symptoms;(4)Uncontrolled or symptomatic congestive heart failure (NYHA> grade 2);(5)Left ventricular ejection fraction below the lower limit of the normal range. Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
Sites / Locations
- Institute of Hematology & Blood Diseases Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
AZA+VEN
DA/IA 3+7
DA/IA 2+5+VEN
Arm Description
Two courses of azacitidine combined with venetoclax as induction regimen
Daunorubicin or Idarubicin ×3 days combined with cytarabine × 7 days as induction regimen
Daunorubicin or Idarubicin ×2 days, cytarabine × 5 days combined with venetoclax as induction regimen
Outcomes
Primary Outcome Measures
Event-free survival (EFS)
It is defined as the time from the start of randomization to the occurrence of induction failure or disease progression or death from any cause (whichever occurs first).
Secondary Outcome Measures
Complete remission (CR) rate or complete remission with partial hematologic recovery (CRh) rate or complete remission with incomplete hematologic recovery (CRi) rate
Proportion of patients with CR, CRh or CRi
Minimal residual disease (MRD)-negative remission rates after induction
Among those who have achieved CR/CRh/CRi after induction, proportion of patients who is MRD-negative
Cumulative incidence of minimal residual disease (MRD)-negative remission rates
The proportion of patients with negative MRD results at any time during treatment
Relapse-free Survival (RFS)
It is defined as the time from the start of achieving remission to disease progression, death from any cause or the last follow-up.
Overall survival (OS)
It is defined as the time from the start of randomization to the death from any cause.
30-day postinduction mortality
It is defined as death from any cause within 30 days after the start of induction.
60-day postinduction mortality
It is defined as death from any cause within 60 days after the start of induction.
Full Information
NCT ID
NCT06066242
First Posted
September 27, 2023
Last Updated
September 27, 2023
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT06066242
Brief Title
Optimizing Induction Chemotherapy Regimens for ND Elderly AML Patients Who Are Eligible for Intense Chemotherapy
Official Title
Optimizing Induction Chemotherapy Regimens for Newly Diagnosed Elderly Acute Myeloid Leukemia Patients Who Are Eligible for Intense Chemotherapy: A Multicenter, Randomized, Controlled Phase II Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 10, 2023 (Anticipated)
Primary Completion Date
October 10, 2025 (Anticipated)
Study Completion Date
October 10, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The optimal induction chemotherapy regimen for newly diagnosed elderly AML patients who are eligible for intense chemotherapy is currently not well defined. Thus, we intend to conduct a multicenter, randomized, controlled clinical trial to compare the safety and efficacy of three different induction regimens (Ven+AZA vs DA/IA 3+7 vs DA/IA 2+5+VEN). A total of 90 patients will be enrolled in this study and segregated into thress groups with 30 in each group. Patients who achieve CR/CRi/CRh after using different induction regimens will receive the same consolidation and maintenance therapy. Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity. After completion of the treatment phase, patients entered the follow-up period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
elderly, newly diagnosed, fit, induction regimen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AZA+VEN
Arm Type
Experimental
Arm Description
Two courses of azacitidine combined with venetoclax as induction regimen
Arm Title
DA/IA 3+7
Arm Type
Experimental
Arm Description
Daunorubicin or Idarubicin ×3 days combined with cytarabine × 7 days as induction regimen
Arm Title
DA/IA 2+5+VEN
Arm Type
Experimental
Arm Description
Daunorubicin or Idarubicin ×2 days, cytarabine × 5 days combined with venetoclax as induction regimen
Intervention Type
Other
Intervention Name(s)
Different induction chemotherapy regimens
Intervention Description
azacitidine combined with venetoclax or chemotherapy with or without venetoclax
Primary Outcome Measure Information:
Title
Event-free survival (EFS)
Description
It is defined as the time from the start of randomization to the occurrence of induction failure or disease progression or death from any cause (whichever occurs first).
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
Complete remission (CR) rate or complete remission with partial hematologic recovery (CRh) rate or complete remission with incomplete hematologic recovery (CRi) rate
Description
Proportion of patients with CR, CRh or CRi
Time Frame
Up to approximately eight weeks
Title
Minimal residual disease (MRD)-negative remission rates after induction
Description
Among those who have achieved CR/CRh/CRi after induction, proportion of patients who is MRD-negative
Time Frame
Up to approximately eight weeks
Title
Cumulative incidence of minimal residual disease (MRD)-negative remission rates
Description
The proportion of patients with negative MRD results at any time during treatment
Time Frame
Up to approximately 1 years
Title
Relapse-free Survival (RFS)
Description
It is defined as the time from the start of achieving remission to disease progression, death from any cause or the last follow-up.
Time Frame
Up to approximately 2 years
Title
Overall survival (OS)
Description
It is defined as the time from the start of randomization to the death from any cause.
Time Frame
Up to approximately 2 years
Title
30-day postinduction mortality
Description
It is defined as death from any cause within 30 days after the start of induction.
Time Frame
Up to approximately 30 days
Title
60-day postinduction mortality
Description
It is defined as death from any cause within 60 days after the start of induction.
Time Frame
Up to approximately 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to understand the study and voluntarily sign informed consent.
Age: 60~75 years old, gender unlimited.
Patients diagnosed with acute myeloid leukemia according to "The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia" who haven't been treated.
Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2.
Fit for intensive chemotherapy.
The function of main organs should meet the following standards before treatment: Kidney: serum creatinine ≤ 2× upper limit of normal range (ULN); Liver: total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5× ULN; Heart: myocardial enzymes ≤ 2× ULN and normal ejection fraction by cardiac color doppler ultrasound
Exclusion Criteria:
Patients with acute promyelocytic leukemia
Patients with RUNX1::RUNX1T1 or CBFB::MYH11 fusion gene
Patients with BCR::ABL fusion gene
Patients who have received a prior treatment for AML with chemotherapy, hypomethylating agents or venetoclax before.
Patients with concurrent malignant tumors requiring treatment
Patients with active heart disease defined as one or more of the following: (1) Uncontrolled or symptomatic angina pectoris;(2) A myocardial infarction 6 months before enrolled; (3)Arrhythmia needed medication or with severe clinical symptoms;(4)Uncontrolled or symptomatic congestive heart failure (NYHA> grade 2);(5)Left ventricular ejection fraction below the lower limit of the normal range.
Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Wei, MD
Phone
86-022-23909020
Email
weihui@ihcams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Wei, MD
Organizational Affiliation
Institute of Hematology & Blood Diseases Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Hematology & Blood Diseases Hospital
City
Tianjin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Wei, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Optimizing Induction Chemotherapy Regimens for ND Elderly AML Patients Who Are Eligible for Intense Chemotherapy
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