Combining Clifutinib Besylate with Chemotherapy for Newly Diagnosed Acute Myeloid Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Jie Jin, Doctor
• Email: jiej0503@163.com
• Phone: 0571-87236685

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Venetoclax and Azacitidine with or without Quizartinib in older/unfit adults with AML

  This trial tests whether adding Quizartinib to Venetoclax and Azacitidine helps older or unfit adults with AML live longer compared with the standard Venetoclax and Azacitidine therapy.

  Recruiting at 24 sites Phase 3 PETHEMA Foundation · Santiago de Compostela, A Coruña and 51 other locations · NCT07478991

• Combining revumenib with azacitidine and venetoclax for treating specific types of acute myeloid leukemia

  This study is testing a new combination of medications to see if it can help people with specific types of acute myeloid leukemia who can't have intensive chemotherapy.

  Recruiting at 128 sites Phase 3 Stichting Hemato-Oncologie voor Volwassenen Nederland · Los Angeles, California and 200 other locations · NCT06652438

• Comparing different drug combinations for newly diagnosed acute myeloid leukemia

  This study is testing different combinations of drugs to see which one works best for people with newly diagnosed acute myeloid leukemia who can't handle strong chemotherapy.

  Recruiting Phase 2 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT06532552

• Real-world outcomes for adults with AML treated with new drugs (BoxTrial)

  This project will follow adults with AML treated in routine care across Italy to see how new approved drugs and combinations perform over at least two years.

  Recruiting at 2 sites Gruppo Italiano Malattie EMatologiche dell'Adulto · San Giovanni Rotondo and 1 other locations · NCT06513273

• Multi-peptide vaccine with XS15 for adults with acute myeloid leukemia in remission

  A small early study will test a multi-peptide vaccine with XS15 to see if it’s safe and can trigger immune responses in AML patients who are in complete remission after first-line therapy.

  Recruiting Phase 1 University Hospital Tuebingen · Tübingen, Baden-Wurttemberg · NCT06252584

• Hydroxyurea plus valproic acid or 6‑mercaptopurine plus valproic acid for unfit adults with AML or high‑risk MDS

  This study will try two low‑toxicity oral drug combinations—hydroxyurea plus valproic acid, or 6‑mercaptopurine plus valproic acid—in adults with acute myeloid leukemia or high‑risk myelodysplastic syndrome who are not fit for standard chemotherapy.

  Recruiting Phase 1/2 Haukeland University Hospital · Bergen, Bergen · NCT06199557

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.