Acute Myeloid Leukemia
Conditions
Keywords
elderly, newly diagnosed, fit, induction regimen
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 screen the safety and efficacy of two induction regimens (Ven+AZA and DA/IA 2+5+VEN) in order to select one as the experimental arm in the sebsequent 3 phase RCT study. A total of 90 patients will be enrolled in this study and segregated into three 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.
Interventions
OTHERDifferent induction chemotherapy regimens
azacitidine combined with venetoclax or chemotherapy with or without venetoclax
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Able to understand the study and voluntarily sign informed consent. 2. Age: 60\~75 years old, gender unlimited. 3. 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. 4. Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2. 5. Fit for intensive chemotherapy. 6. 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
1. Patients with acute promyelocytic leukemia 2. Patients with RUNX1::RUNX1T1 or CBFB::MYH11 fusion gene 3. Patients with BCR::ABL fusion gene 4. Patients who have received a prior treatment for AML with chemotherapy, hypomethylating agents or venetoclax before. 5. Patients with concurrent malignant tumors requiring treatment 6. 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. 7. Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival (EFS) | Up to approximately 2 years | 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
| Measure | Time frame | Description |
|---|---|---|
| 30-day postinduction mortality | Up to approximately 30 days | It is defined as death from any cause within 30 days after the start of induction. |
| Complete remission (CR) rate or complete remission with partial hematologic recovery (CRh) rate or complete remission with incomplete hematologic recovery (CRi) rate | Up to approximately eight weeks | Proportion of patients with CR, CRh or CRi |
| Minimal residual disease (MRD)-negative remission rates after induction | Up to approximately eight weeks | 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 | Up to approximately 1 years | The proportion of patients with negative MRD results at any time during treatment |
| Relapse-free Survival (RFS) | Up to approximately 2 years | 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) | Up to approximately 2 years | It is defined as the time from the start of randomization to the death from any cause. |
| 60-day postinduction mortality | Up to approximately 60 days | It is defined as death from any cause within 60 days after the start of induction. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORHui Wei, MD
Institute of Hematology & Blood Diseases Hospital, China
Outcome results
None listed