New combo shows promise for Tough-to-Treat leukemia
NCT ID NCT07517510
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of three drugs (homoharringtonine, venetoclax, and azacitidine) in 40 adults newly diagnosed with a rare and aggressive leukemia called mixed-phenotype acute leukemia (MPAL). The goal is to see if this drug combo can safely help more patients achieve remission. Participants will receive the treatment and be monitored for response and side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
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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18 years and older
- 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.
Show the full entry requirements Hide the full entry requirements
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 patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF); 2. Age ≥18 years; 3. Newly diagnosed with MPAL according to the World Health Organization (WHO) 2022 classification. 4. The patient has not started anti-leukemia treatment after the initial diagnosis (except cytoreductive therapy, such as hydroxyurea or cytarabine \<1.0 g/day or glucocorticoids); 5. Expected survival ≥12 weeks; 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2; 7. Normal cardiac function, left ventricular ejection fraction ≥50%; normal renal function: creatinine clearance ≥30 ml/min; normal liver function: ALT \<5 times the normal value, bilirubin \<3 times the normal value; Exclusion Criteria: 1. Patients who have had or currently have other malignant tumors requiring treatment; 2. Patients with central nervous system (CNS) infiltration; 3. Other clinically significant uncontrolled conditions, including but not limited to: (1) uncontrolled or active systemic infections (viral, bacterial, or fungal); (2) chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; (3) uncontrolled hypertension, etc.; 4. Patients who cannot take oral medications or have malabsorption syndrome; 5. Patients with a known history of immediate or delayed hypersensitivity reactions to drugs of the same class as the study medication or to excipients; 6. Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study; 7. Patients with a history of severe neurological or psychiatric disorders who cannot understand or comply with the study protocol; 8. Patients with severe heart disease, such as myocardial infarction, severe or unstable angina, severe arrhythmias; 9. Patients known to be infected with human immunodeficiency virus (HIV); patients with active hepatitis B or C; subjects who are inactive hepatitis carriers or whose viral hepatitis titers are low after treatment with non-prohibited antiviral drugs are not excluded; 10. Patients who cannot take oral medications or have malabsorption syndrome; 11. Patients whom the investigator determines are unsuitable to participate in this study.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Hematology, Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China