Actively Recruiting
A Phase Ib/II Multi-center Open Clinical Trial of Clifutinib Besylate Combined With Chemotherapy in Newly-treated Adult Subjects With Acute Myeloid Leukemia
Led by Sunshine Lake Pharma Co., Ltd. · Updated on 2026-05-15
133
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of Clifutinib Besylate combined with chemotherapy in adults newly diagnosed with acute myeloid leukemia (AML). This open, multi-center clinical trial aims to explore appropriate dosing through dose escalation and to study drug interactions and gene changes related to treatment response. The study also investigates pharmacokinetic properties and correlations between AML subtypes and outcomes. Participants receive Clifutinib Besylate combined with either DA chemotherapy (Daunorubicin and Cytarabine) or AZA (Azacitidine). Different dosing schedules are tested: Clifutinib Besylate is given once daily at doses of 30mg, 40mg, or 60mg, with DA treatment on days 1 to 7 or AZA on days 1 to 7 depending on the group. Treatment includes induction, consolidation, and maintenance phases, with oral Clifutinib continued until disease progression or unacceptable side effects. Throughout the study, participants undergo safety and efficacy assessments including monitoring of the maximum tolerated dose, complete remission rates, response duration, and survival up to 12 months. Researchers also collect data on pharmacokinetics and gene changes before and after treatment. The total participation time varies, with ongoing treatment and follow-up visits to evaluate outcomes and monitor for adverse effects.
CONDITIONS
Brief Title
A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years, with certain older adults eligible in dose escalation and extension phases
- Newly diagnosed with AML, including primary AML or AML secondary to MDS, not previously treated
- FLT3-ITD mutation positive required for extension phase
- ECOG performance status 0-1 for younger adults; 0-2 for older adults (≥60 years); 0-3 for ages 18-59 not tolerating strong chemotherapy
- Expected survival time of at least 12 weeks
- Adequate organ function
- Voluntary participation with signed informed consent
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL) with t(15;17) translocation or BCR-ABL positive leukemia
- AML secondary to prior chemotherapy/radiotherapy for other tumors or prior FLT3 inhibitor use
- AML secondary to myeloproliferative neoplasm or acute lymphoblastic leukemia
- Past or present central nervous system leukemia infiltration
- Other cancers within 5 years before treatment
- Thrombosis or embolism in the 12 months before treatment
- Poor lung function or need for continuous oxygen
- Uncontrolled active infections
- Gastrointestinal problems affecting drug intake or absorption
- History of psychotropic drug abuse or mental disorders
- Other severe acute or chronic diseases unsuitable for trial participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days per treatment cycle, repeated until disease progression or unacceptable toxicity
Participants receive Clifutinib Besylate combined with chemotherapy agents Daunorubicin and Cytarabine or Azacitidine as part of an induction and consolidation therapy. Treatment duration varies by dose groups and continues until disease progression or unacceptable toxicity occurs.
Multiple visits during each treatment cycle as per protocol
Duration - Up to 12 months
Participants are monitored for treatment response, safety, and survival outcomes for up to 12 months after treatment.
Regular follow-up visits during 12 months
Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital,College of Medicine,Zhejiang University
Hanzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
J
Jie Jin, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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