New pill combo aims to tackle tough leukemia
NCT ID NCT05133882
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a new targeted drug called crifortinib besylate (taken as a pill) combined with standard chemotherapy in adults who have just been diagnosed with acute myeloid leukemia (AML). The trial has two phases: first, finding the best dose, then testing it in a larger group, especially in patients with a specific genetic change (FLT3 mutation). About 133 people will take part. The goal is to see if the combination helps control the disease better than chemo alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- crifortinib besylate (a targeted cancer drug taken as a pill)
- What this could lead to
- If successful, this combination could offer a new treatment option for adults with acute myeloid leukemia, especially those with a FLT3 mutation.
- What could go wrong
- This is an early-phase trial (phase 1/2) with a small number of participants, so the drug may not prove effective or safe enough for wider use. Side effects from the drug or chemotherapy are possible.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 133 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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.Cohort 1: 18 years old ≤ age ≤65 years old;Cohort 2: The dose escalation trial only included AML subjects aged ≥60 years; the extended trial included subjects who were ≥60 years old or between 18 and 59 years old (including 18 and 59 years old) and could not tolerate strong chemotherapy. 2.It can be primary AML or AML secondary to MDS, and has not been treated; the extension phase requires the subject to be positive for the FLT3-ITD mutation. 3.The ECOG score according to the requirements of different groups is as follows: Cohort 1: 0\~1 points; Cohort 2: Age ≥60 years old: 0\~2 points; Age 18\~59 years old (including 18 and 59 years old): 0\~3 points. 4.Expected survival time ≥ 12 weeks. 5. Subjects must have adequate organ function. 6.subjects voluntarily participated in the study, and signed a written informed consent form by themselves or their guardians. Exclusion Criteria: * 1.Diagnosed as APL and manifested as t(15;17)(q22;q12) chromosomal translocation, or BCR-ABL positive leukemia;Diagnosed as secondary to AML due to previous chemotherapy or radiotherapy of other tumors; previously received FLT3 inhibitor. 2.AML secondary to myeloproliferative tumor (MPN) or acute lymphoblastic leukemia (ALL). 3.Subjects who have infiltrated the central nervous system in the past or present. 4.Concomitant with other malignant tumors within 5 years before the first medication. 5.Thrombosis or embolism occurred within 12 months before the first medication. 6.Pulmonary function tests indicate that subjects have DLCO ≤50% or FEV1 ≤60%, or have difficulty breathing during rest or require continuous oxygen inhalation. 7.Subjects with uncontrollable, active infections。 8.Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or subjects undergoing total gastrectomy。 9.Subjects with a history of psychotropic drug abuse and unable to quit or those with mental disorders。 10.Researchers believe that those who have other severe acute or chronic diseases who are not suitable for participating in clinical trials.
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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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the First Affiliated Hospital,College of Medicine,Zhejiang University
RECRUITINGHanzhou, Zhejiang, 310003, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a targeted pill boost standard therapy for hard-to-treat leukemia?
- Engineered immune cells take aim at Hard-to-Treat leukemia
- New drug cocktail aims to beat back stubborn leukemia
- New triple therapy aims to boost survival in frail AML patients
- Promising chemo cocktail shows hope for AML patients under 60
- New hope for older AML patients: study tests smarter drug combos to beat relapse