Combination therapy for newly diagnosed acute myeloid leukemia

Clinical Study Protocol of Idarubicin, Cytarabine, and Venetoclax -Induced Remission Followed by Consolidation Therapy With Medium-dose Cytarabine Combined With Venetoclax in Newly Diagnosed Adult Acute Myeloid Leukemia

This study is testing a new combination of drugs to see if it helps adults with newly diagnosed acute myeloid leukemia feel better and improve their treatment outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06232694 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 60 years with newly diagnosed primary acute myeloid leukemia.

Not a fit: Patients with acute promyelocytic leukemia, relapsed or refractory AML, or known CNS involvement are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could improve remission rates and overall survival for patients with newly diagnosed AML.

How similar studies have performed: Previous studies have shown promising results with similar treatment regimens, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Nanjing, Jiangsu

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

Study contacts

• Study coordinator: Ming Hong, MD

Conditions Acute Myeloid Leukemia