Status:
RECRUITING
Optimizing Induction Chemotherapy Regimens for ND Elderly AML Patients Who Are Eligible for Intense Chemotherapy
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
60-75 years
Phase:
NA
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, r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06066242
Start Date
October 1 2023
End Date
October 10 2025
Last Update
May 30 2025
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China