Treatment of relapsed or refractory acute myeloid leukemia with a new drug combination

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 trial investigates the safety and efficacy of a new treatment regimen combining Chiglitazar Sodium, Venetoclax, and Azacitidine for patients with relapsed or refractory acute myeloid leukemia (R/R AML). Participants will receive a specific dosing schedule over multiple cycles, with adjustments made based on drug concentration levels. The study aims to assess the treatment's effectiveness and safety profile, with options for further treatment if initial responses are stable or progressive. Patients who do not show improvement after two cycles may be withdrawn and considered for alternative therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Acute myeloid leukemia (AML) confirmed by histology. Relapsed or refractory AML, including: a) Refractory disease is defined as no remission after at least one prior treatment. b) Disease relapse is defined as 5% or more blasts in the bone marrow after remission. c) Patients with AML arising from myelodysplastic syndromes (including CMML) or myeloproliferative neoplasms (secondary AML, t-AML) are also eligible;
2. Age ≥18 years, male or female, with an expected survival of more than 3 months;
3. Estimated creatinine clearance ≥ 50 mL/min;
4. AST and ALT ≤ 3.0 x ULN (unless considered due to leukemia organ involvement), bilirubin ≤ 3.0 x ULN (unless considered due to leukemia organ involvement);
5. ECOG ≤ 2;
6. Subjects are non-pregnant or using contraceptive measures during treatment;
7. Capable of understanding and voluntarily providing informed consent.

Exclusion Criteria:

1. Acute promyelocytic leukemia (APL);
2. Active central nervous system leukemia;
3. Patients with clinically significant QTc interval prolongation (males \> 450 ms; females \> 470 ms), ventricular tachycardia and atrial fibrillation, second-degree heart block, history of myocardial infarction and congestive heart failure within the year prior to enrollment, and patients with clinically symptomatic coronary heart disease requiring medication;
4. Active, uncontrolled severe infection;
5. Other non-myeloid malignancies within the past 2 years;
6. Mental disorders that would impede study participation;
7. Previous solid organ transplantation (pre-treatment with SCT is allowed, but not allowed if the patient has GVHD or is still receiving immunosuppressive/GVHD treatment);
8. Any other conditions that, in the opinion of the investigator, make the patient unsuitable to participate in this trial.

Where it's running

• The First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Recruiting

Study contacts

• Principal investigator: Bing Xu — The First Aiffiliated hosptical of xiamen University
• Study coordinator: Bing Xu
• Email: xubingzhangjian@126.com
• Phone: 18750918842

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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.