Acute Myeloid Leukemia, AdultPhase 1/2NCT05133882
A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML
A Phase 1/2 study testing Clifutinib Besylate in people with Acute Myeloid Leukemia, Adult, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Adult
- What is being tested?
- Clifutinib Besylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2022to 30 Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital,College of Medicine,Zhejiang University
Hanzhou, Zhejiang, 310003
Jie Jin, Doctor, 0571-87236685, jiej0503@163.com
About this study
Official title: 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
Read the detailed description
Main purpose:To evaluate the tolerability and safety of Clifutinib Besylate combined with DA (Cytarabine + Daunorubicin) or AZA (Azacitidine) in newly-treated adult AML subjects; explore reasonable therapeutic doses through climbing tests in different dose groups.
To evaluate the efficacy of Clifutinib Besylate combined with DA or AZA in newly treated adult AML subjects.
Secondary purpose:To observe the pharmacokinetic (PK) characteristics of Clifutinib combined with DA or AZA in newly-treated adult AML subjects and the drug interaction between Clifutinib and AZA at the same time.Observe the correlation of different subtypes and prognostic risk with the efficacy of Clifutinib and the changes of genes before and after treatment.
- Conditions
- Acute Myeloid Leukemia, Adult
- Being tested
- Clifutinib Besylate
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clifutinib BesylateDrug
Also called HEC73543
The queue 1 is divided into Induction therapy and Consolidation therapy and Maintenance treatment The queue 2 will receive oral Clifutinib Besylate once daily until disease progression or unacceptable toxicity occurs
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Queue 1:Clifutinib Besylate:30mg qd d8-21;Daunorubicin 60 mg/m2 qd d1-3;Cytarabine 100 mg/m2 qd d1-7 Queue 1:Clifutinib Besylate:30mg qd d1-28 ;Azacitidine 75 mg/m2 qd d1-7 Receives: Drug: Clifutinib Besylate |
| Arm 2 | Experimental | Queue 1:Clifutinib Besylate:40mg qd d8-21;Daunorubicin 60 mg/m2 qd d1-3;Cytarabine 100 mg/m2 qd d1-7 Queue 1:Clifutinib Besylate:40mg qd d1-28 ;Azacitidine 75 mg/m2 qd d1-7 Receives: Drug: Clifutinib Besylate |
| Arm 3 | Experimental | Queue 1:Clifutinib Besylate:60mg qd d8-21;Daunorubicin 60 mg/m2 qd d1-3;Cytarabine 100 mg/m2 qd d1-7 Queue 1:Clifutinib Besylate:60mg qd d1-28 ;Azacitidine 75 mg/m2 qd d1-7 Receives: Drug: Clifutinib Besylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose(MTD)
Safety and Tolerability assessed through adverse events to determine maximum tolerated dose
Measured: day 1-28
Composite CR rate
CR + CRi +CRMRD-
Measured: Up to 12 months
Secondary outcomes (4)
Duration of response
The time from receive CR / CRi/CRMRD-/PR to relapse
Measured: up to 12 months
Objective response rate
CR + CRi +CRMRD- + PR
Measured: up to 12 months
Event Free Survival
From the first time taking experimental drug to treatment failure or progression or relapse or death
Measured: up to 12 months
Overall Survival
From the first time taking experimental drug to death
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start31 Oct 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia, AdultStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Arm 1:30 mg Arm 2:40 mg Arm 3:60 mg
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jie Jin, Doctor, Study chair, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133882
- Sponsor's protocol ID
- HEC73543-AML-102
- Status last verified
- May 2026
- First submitted
- 12 Nov 2021
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II, Multi-center, Open Clinical Trial of Crifortinib Besylate Combined With Chemotherapy in Newly-treated Adult Subjects With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05133882
- Acronym / sponsor ID
- HEC73543-AML-102
- Conditions
- Acute Myeloid Leukemia, Adult
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Main purpose:To evaluate the tolerability and safety of Clifutinib Besylate combined with DA (Cytarabine + Daunorubicin) or AZA (Azacitidine) in newly-treated adult AML subjects; explore reasonable therapeutic doses through climbing tests in different dose groups.
To evaluate the efficacy of Clifutinib Besylate combined with DA or AZA in newly treated adult AML subjects.
Secondary purpose:To observe the pharmacokinetic (PK) characteristics of Clifutinib combined with DA or AZA in newly-treated adult AML subjects and the drug interaction between Clifutinib and AZA at the same time.Observe the correlation of different subtypes and prognostic risk with the efficacy of Clifutinib and the changes of genes before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Arm 1:30 mg Arm 2:40 mg Arm 3:60 mg
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Clifutinib BesylateQueue 1:Clifutinib Besylate:30mg qd d8-21;Daunorubicin 60 mg/m2 qd d1-3;Cytarabine 100 mg/m2 qd d1-7 Queue 1:Clifutinib Besylate:30mg qd d1-28 ;Azacitidine 75 mg/m2 qd d1-7 |
| Arm 2 | Experimental | Drug: Clifutinib BesylateQueue 1:Clifutinib Besylate:40mg qd d8-21;Daunorubicin 60 mg/m2 qd d1-3;Cytarabine 100 mg/m2 qd d1-7 Queue 1:Clifutinib Besylate:40mg qd d1-28 ;Azacitidine 75 mg/m2 qd d1-7 |
| Arm 3 | Experimental | Drug: Clifutinib BesylateQueue 1:Clifutinib Besylate:60mg qd d8-21;Daunorubicin 60 mg/m2 qd d1-3;Cytarabine 100 mg/m2 qd d1-7 Queue 1:Clifutinib Besylate:60mg qd d1-28 ;Azacitidine 75 mg/m2 qd d1-7 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clifutinib BesylateAlso: HEC73543The queue 1 is divided into Induction therapy and Consolidation therapy and Maintenance treatment The queue 2 will receive oral Clifutinib Besylate once daily until disease progression or unacceptable toxicity occurs | Drug | Arm 1, Arm 2, Arm 3 |
Primary outcome
Maximum tolerated dose(MTD)
Time frame: day 1-28
Safety and Tolerability assessed through adverse events to determine maximum tolerated dose
Composite CR rate
Time frame: Up to 12 months
CR + CRi +CRMRD-
4 secondary outcomes
Duration of response
Time frame: up to 12 months
Objective response rate
Time frame: up to 12 months
Event Free Survival
Time frame: up to 12 months
Overall Survival
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jie Jin, Doctor study chair
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Clifutinib Besylate in people with Acute Myeloid Leukemia, Adult, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Jin, Doctor (0571-87236685, jiej0503@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose(MTD) (time frame: day 1-28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.