Tests clifutinib besylate with chemotherapy in adults with newly diagnosed acute myeloid leukemia
Tests clifutinib besylate plus chemotherapy in adults newly diagnosed with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML
Key facts
- Where
- Hanzhou, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed acute myeloid leukemia (AML) who have not been treated yet. They will get Clifutinib Besylate together with chemotherapy.
- Age
- Cohort 1: 18 to 65 years. Cohort 2: 60 years or older; in the extension part also 18 to 59 years if strong chemotherapy cannot be tolerated.
- Sex
- All sexes can join.
- Disease stage
- Primary AML, or AML secondary to MDS, not treated yet. Expected survival of at least 12 weeks. ECOG score 0 to 1 in Cohort 1; 0 to 2 (age 60 or older) or 0 to 3 (age 18 to 59) in Cohort 2.
- Earlier treatment
- No earlier treatment for AML. Anyone who previously received a FLT3 inhibitor cannot join.
- Biomarker or test result
- In the extension phase, the FLT3-ITD mutation must be positive.
Main reasons for not taking part
- APL with t(15;17)(q22;q12), or BCR-ABL positive leukemia
- AML secondary to earlier chemotherapy or radiotherapy for another tumor, to a myeloproliferative tumor (MPN), or acute lymphoblastic leukemia (ALL)
- Past or present leukemia in the central nervous system
- Uncontrolled, active infection
- Another cancer within 5 years, or a blood clot or embolism within 12 months before the first dose
Read by machine on 12 November 2026.
Where in China
- the First Affiliated Hospital,College of Medicine,Zhejiang UniversityHanzhou, ChinaContact: Jie Jin, DoctorTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sunshine Lake Pharma Co., Ltd.
- Trial code
- NCT05133882
- Record updated
- 15 May 2026
- Original description
This is a multi-center open clinical study aimed at evaluating the efficacy and safety of Clifutinib Besylate combined with chemotherapy in newly-treated adult subjects with AMLRead full original descriptionShow less
A Phase Ib/II, Multi-center, Open Clinical Trial of Crifortinib Besylate Combined With Chemotherapy in Newly-treated Adult Subjects With Acute Myeloid Leukemia
This is a multi-center open clinical study aimed at evaluating the efficacy and safety of Clifutinib Besylate combined with chemotherapy in newly-treated adult subjects with AML
Inclusion: 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: 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.