Higher chemo dose may boost survival in rare leukemia subtype
NCT ID NCT06744504
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This Phase 3 trial is testing whether a higher dose of the chemotherapy drug cytarabine, given with standard drugs, improves survival for people with acute myeloid leukemia (AML) that has a specific genetic change called RUNX1-RUNX1T1. The study will enroll 300 adults aged 14 to 60. Participants will be randomly assigned to receive either a standard or intermediate dose of cytarabine during their first round of treatment, followed by additional therapy. The main goal is to see if the higher dose leads to longer overall survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cytarabine combined with daunorubicin, idarubicin, or cyclophosphamide
- What this could lead to
- If successful, this could show that a higher dose of cytarabine during initial treatment improves survival for people with a specific type of AML.
- What could go wrong
- This is a Phase 3 trial, but it focuses on a rare genetic subtype of AML. Higher chemotherapy doses may increase side effects and risks without guaranteeing better outcomes.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 284 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2029
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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14 to 60 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.
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. AML conforming to WHO (2022) or ICC standards 2. Possessing the RUNX1::RUNX1T1 fusion gene 3. Age ranging from 14 to 60 years old, regardless of gender. 4. The performance status assessment of the Eastern Cooperative Oncology Group (ECOG-PS) being 0 - 2. 5. Meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment): 1\) Total bilirubin ≤ 1.5 times the upper limit of the normal value for the same age group; 2) AST and ALT ≤ 2.5 times the upper limit of the normal value for the same age group; 3) Serum creatinine \< 2 times the upper limit of the normal value for the same age group; 4) Cardiac enzymes \< 2 times the upper limit of the normal value for the same age group; 5) The cardiac ejection fraction determined by echocardiography (ECHO) \> 50%. An informed consent form must be signed before the commencement of all specific research procedures, either by the patient themselves or their immediate relatives. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the informed consent form shall be signed by the legal guardian or the immediate relatives of the patient. Exclusion Criteria: 1. Acute promyelocytic leukemia accompanied by PML-RARA fusion gene. 2. Acute myeloid leukemia featuring BCR-ABL fusion gene. 3. Patients undergoing retreatment (but can receive cytoreductive therapy with hydroxyurea and cytarabine). 4. Individuals concurrently having malignant tumors in other organs (requiring treatment). 5. Active cardiac disorders, defined as one or more of the following: 1\) A history of uncontrolled or symptomatic angina pectoris; 2) Myocardial infarction less than 6 months from study enrollment; 3) A history of significant arrhythmia requiring medication or presenting with severe clinical symptoms; 4) Uncontrolled or symptomatic congestive heart failure (\> NYHA Class 2) 6\. Severe infectious diseases (untreated tuberculosis, pulmonary aspergillosis). 7\. Individuals deemed ineligible for enrollment by the investigator.
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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
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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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Blood Diseases Hospital
RECRUITINGTianjin, Tianjin Municipality, 300020, China
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Other studies related to the condition(s) this trial covers.
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