New hope for elderly leukemia patients: which chemo works best?
NCT ID NCT06066242
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to find the safest and most effective initial chemotherapy for older adults (60-75) newly diagnosed with acute myeloid leukemia who can handle strong treatment. About 90 participants will be randomly assigned to one of two drug combinations or a standard treatment. The goal is to improve survival without the cancer returning, while managing side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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113 people
The number who actually took part.
- Started
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Oct 2023
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Institute of Hematology & Blood Diseases Hospital
Tianjin, China
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Other studies related to the condition(s) this trial covers.
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