Combining Clifutinib Besylate with Chemotherapy for Newly Diagnosed Acute Myeloid Leukemia

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 study is testing if adding Clifutinib Besylate to standard chemotherapy helps adults who are newly diagnosed with Acute Myeloid Leukemia feel better and respond to treatment.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 133 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sunshine Lake Pharma Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, Clifutinib
• Locations: 1 site (Hanzhou, Zhejiang)
• Trial ID: NCT05133882 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and efficacy of Clifutinib Besylate when combined with standard chemotherapy regimens in adults newly diagnosed with Acute Myeloid Leukemia (AML). It includes a multi-center approach to assess tolerability and determine optimal dosing through dose escalation tests. The study also aims to observe the pharmacokinetics of Clifutinib and its interaction with chemotherapy agents, while exploring the relationship between genetic subtypes and treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with newly diagnosed AML, including those with specific genetic mutations.

Not a fit: Patients diagnosed with Acute Promyelocytic Leukemia (APL) or those who have previously received treatment for AML may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with newly diagnosed AML by providing a more effective therapeutic option.

How similar studies have performed: While there have been studies on chemotherapy combinations for AML, the specific combination of Clifutinib Besylate with these regimens is novel and has not been extensively tested.

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.

Where this trial is running

Hanzhou, Zhejiang

• the First Affiliated Hospital,College of Medicine,Zhejiang University — Hanzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Jie Jin, Doctor

Conditions Acute Myeloid Leukemia, Adult