Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06232694

Clinical Study Protocol of IAV-induced Remission Followed by Consolidation Therapy With MDCyta+Ven in ND-AML

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-01-01

Completion Date

2027-12-30

Last Updated

2024-01-31

Healthy Volunteers

Conditions

Acute Myeloid Leukemia

Interventions

DRUG

Venetoclax : 100mg on day 1, 200mg on day 2, 400mg on days 3 to 8; oral administration;

Induction Phase Regimen

DRUG

Venetoclax (Venetoclax): 400mg on day 1 to day 7; oral administration;

Consolidation therapy after remission

OTHER

utologous stem cell transplantation (ASCT) /allogeneic hematopoietic stem cell transplantation (allo-HSCT).

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).

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.

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China