Clinical trial NCT06066242: 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
Overall status: RECRUITING
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: elderly
newly diagnosed
fit
induction regimen
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Event-free survival (EFS)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Complete remission (CR) rate or complete remission with partial hematologic recovery (CRh) rate or complete remission with incomplete hematologic recovery (CRi) rate
timeFrame: Up to approximately eight weeks
measure: Minimal residual disease (MRD)-negative remission rates after induction
timeFrame: Up to approximately eight weeks
measure: Cumulative incidence of minimal residual disease (MRD)-negative remission rates
timeFrame: Up to approximately 1 years
measure: Relapse-free Survival (RFS)
timeFrame: Up to approximately 2 years
measure: Overall survival (OS)
timeFrame: Up to approximately 2 years
measure: 30-day postinduction mortality
timeFrame: Up to approximately 30 days
measure: 60-day postinduction mortality
timeFrame: Up to approximately 60 days
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
Study officials:
affiliation: Institute of Hematology & Blood Diseases Hospital, China
name: Hui Wei, MD
role: PRINCIPAL_INVESTIGATOR
References: