New triple therapy aims to tackle tough leukemia mutation
NCT ID NCT06561880
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of three drugs (gilteritinib, venetoclax, and azacitidine) in people newly diagnosed with acute myeloid leukemia (AML) who have a specific genetic change called FLT3 mutation. The goal is to see if this triple therapy can improve remission rates and survival. About 66 participants aged 15 and older will receive the treatment, and researchers will monitor side effects and 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
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2024
- Expected to finish
-
Aug 2027
An estimate. End dates often move.
- Lead sponsor
-
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
-
14 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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. MDS/AML patients WHO meet AML and ICC definitions according to WHO (2022) or ICC standards (10%-20% of bone marrow naive cells) and have FLT3-TKD or ITD mutations detected by PCR or second-generation sequencing. 2. Age ≥15 years old, male or female. 3. The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points. 4. Pass the requirements of the following laboratory tests (performed within 7 days before treatment) : 1\) Total bilirubin ≤ 1.5 times the upper limit of normal value (same age); 2) AST and ALT≤ 2.5 times the upper limit of normal value (same age); 3) Blood creatinine \< 2 times the upper limit of normal (same age); 4) Myocardial enzymes \< 2 times the upper limit of normal (same age); 5) Echocardiography (ECHO) was performed to determine the ejection fraction of the heart within the normal range. Exclusion Criteria: 1. Acute promyelocytic leukemia with PML-RARA fusion gene 2. Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene 3. Acute myeloid leukemia with BCR-ABL fusion gene 4. Have treated patients (those who have previously received induction chemotherapy but can receive hydroxyurea down-cell therapy). 5. Concurrent malignant tumors of other organs (those requiring treatment). 6. Active heart disease, defined as one or more of the following: 1\) A history of uncontrolled or symptomatic angina; 2) Myocardial infarction less than 6 months after enrollment; 3) Have a history of arrhythmia requiring drug treatment or severe clinical symptoms; 4) Uncontrolled or symptomatic congestive heart failure (\> NYHA level 2); 5) The ejection fraction is lower than the lower limit of the normal range. 7. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis). 8. Those who were not considered suitable for inclusion by the researchers.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for AML are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Blood Diseases Hospital
RECRUITINGTianjin, Tianjin Municipality, 300020, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Breath test aims to classify leukaemia in hours, not days
- Can a Four-Drug prep make curative transplant safer for older AML patients?
- Gentler transplant prep aims to cure tough blood cancers
- Can a Chemo-Transplant combo rescue patients whose leukemia resists standard treatment?
- Can a liposomal chemo combo improve outcomes before stem cell transplant?
- Can a new drug regimen beat the standard for stem cell transplant complications?