NCT05133882 A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML
| NCT ID | NCT05133882 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sunshine Lake Pharma Co., Ltd. |
| Condition | Acute Myeloid Leukemia, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 133 participants |
| Start Date | 2022-10-31 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 133 participants in total. It began in 2022-10-31 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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.
Contact & Investigator
Jie Jin, Doctor
STUDY CHAIR
First Affiliated Hospital of Zhejiang University
Frequently Asked Questions
Who can join the NCT05133882 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05133882 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05133882 currently recruiting?
Yes, NCT05133882 is actively recruiting participants. Contact the research team at jiej0503@163.com for enrollment information.
Where is the NCT05133882 trial being conducted?
This trial is being conducted at Hanzhou, China.
Who is sponsoring the NCT05133882 clinical trial?
NCT05133882 is sponsored by Sunshine Lake Pharma Co., Ltd.. The principal investigator is Jie Jin, Doctor at First Affiliated Hospital of Zhejiang University. The trial plans to enroll 133 participants.
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