Combination therapy 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 study evaluates the effectiveness and safety of a treatment regimen combining idarubicin and cytarabine for induction therapy, followed by intermediate-dose cytarabine and venetoclax for consolidation in adults with newly diagnosed acute myeloid leukemia (AML). It is a prospective, multicenter, open-label, single-arm clinical study designed to gather data on patient outcomes and treatment responses. The study aims to provide insights into the efficacy of this combination therapy, which may guide future clinical practices in AML treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Newly diagnosed primary AML patients. Diagnostic criteria refer to the 2022 WHO classification.
* Age between 18 and 60 years old.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix 2).
* Cardiac ultrasound LVEF ≥ 45%.
* Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula or measured using a 24-hour urine sample).
* Liver function: Aspartate aminotransferase (AST) ≤ 2.5 × ULN\*; Alanine aminotransferase (ALT) ≤ 2.5 × ULN\*; Total bilirubin ≤ 1.5 × ULN\* (\*unless considered due to leukemia infiltration).
* Signed informed consent form.

Exclusion Criteria:

* Acute promyelocytic leukemia (APL).
* Relapsed/refractory AML patients.
* AML patients with known involvement of the central nervous system (CNS).
* Known HIV-infected participants (due to potential drug-drug interactions between antiretroviral drugs and venetoclax). HIV testing will be conducted during screening according to local guidelines or institutional standards.Participants with positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Non-active carriers of viral hepatitis or participants with low viral hepatitis viral titers after receiving non-prohibited antiviral therapy will not be excluded.
* Participants who have received strong or moderate CYP3A inducers/inhibitors therapy within 7 days prior to starting study treatment.
* Participants with New York Heart Association (NYHA) functional classification \> Grade 2. Grade 2 is defined as patients having cardiac disease with no symptoms at rest but experiencing fatigue, palpitations, dyspnea, or angina with ordinary physical activity.
* Participants with chronic respiratory disease requiring continuous oxygen therapy.
* Patients unable to take oral medications or with malabsorption syndrome.
* Presence of uncontrolled systemic infection (viral, bacterial, or fungal).
* Participants who have previously received venetoclax treatment and/or are currently participating in any other study involving investigational drugs.

Where it's running

• The First Affiliated Hospital with Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Ming Hong, MD
• Email: minniehm122@163.com
• Phone: +8613914722662

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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.