Promising chemo cocktail shows hope for AML patients under 60
NCT ID NCT05906914
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a three-drug chemotherapy combination (cladribine, homoharringtonine, and cytarabine) in 65 adults under 60 with newly diagnosed acute myeloid leukemia (AML). The goal was to see how well it wiped out leukemia cells and how safe it was. Results tracked complete remission, survival, and side effects over two years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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65 people
The number who actually took part.
- Started
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Oct 2022
- Finished
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Oct 2025
- 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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18 to 59 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. The age is 18 to 59 years old, gender is not limited, race is not limited. 2. Diagnosed as acute myeloid leukemia (AML) according to the diagnostic criteria of the World Health Organization (WHO) in 2016. 3. No previous anti-acute leukemia therapy (including demethylation drugs for leukemia or myelodysplastic syndrome (MDS), except hydroxyurea and leukocytosis). 4. Physical status \<= 2 according to eastern tumor cooperation group (ECOG). 5. Within 21 days before random grouping and at baseline, biochemical indicators must be within the following limits: Glutamic pyruvic transaminase (ALT) and glutamic oxaloacetic transaminase (AST) \<= 3 × normal upper limit (ULN); total bilirubin \<= 3 × ULN; serum creatinine \<= 2 × ULN or serum creatinine clearance rate (CrCl)\>= 40mL/min. 6. The left ventricular ejection fraction\| (LVEF) measured by echocardiography was in the normal range (LVEF \> 50%). 7. Each patient (or his or her legal representative) must sign an informed consent form (ICF), indicating that he / she understands the purpose and procedures of the study and is willing to participate in the study. Exclusion Criteria: 1. Diagnosed or receiving treatment for other malignant tumors other than AML that are or are in need of treatment in the near future. 2. Acute promyelocytic leukemia, myeloid sarcomas, accelerated and acute transformation of chronic myeloid leukemia. 3. Patients with severe liver and kidney function, cardiopulmonary insufficiency. 4. Uncontrolled or severe infection. 5. Mental illness that may prevent subjects from completing treatment or informed consent.
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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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The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
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Other studies related to the condition(s) this trial covers.
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