Clinical Study Protocol of IAV-induced Remission Followed by Consolidation Therapy With MDCyta+Ven in ND-AML
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
The First Affiliated Hospital with Nanjing Medical University
54 participants
Jan 1, 2024
INTERVENTIONAL
Conditions
Summary
This study evaluates the efficacy and safety of the combination of idarubicin and cytarabine induction followed by intermediate-dose cytarabine consolidation with venetoclax in the treatment of newly diagnosed adult acute myeloid leukemia (AML). This study includes the induction and consolidation phases of AML treatment.
Eligibility
Inclusion Criteria7
- 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 Criteria10
- 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.
Interventions
Induction Phase Regimen
Consolidation therapy after remission
Four cycles in total.Patients who meet the criteria for autologous stem cell transplantation (ASCT) during the treatment process can undergo ASCT.Patients who meet the transplantation criteria and have a suitable donor can undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06232694