Search / Trial NCT06232694

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

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Jan 30, 2024

Trial Information

Current as of October 08, 2024

Recruiting

Keywords

Description

This is a prospective, multicenter, open-label, single-arm clinical study aimed at observing and evaluating the effectiveness and safety of idarubicin and cytarabine induction followed by intermediate-dose cytarabine consolidation therapy in newly diagnosed adult AML. The results of this study will help to understand the efficacy and safety of idarubicin and cytarabine combination therapy followed by intermediate-dose cytarabine consolidation in newly diagnosed adult AML, providing guidance for clinical practice. Acute myeloid leukemia (AML) is a heterogeneous hematopoietic stem/progenitor...

Gender

ALL

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.

About The First Affiliated Hospital With Nanjing Medical University

The First Affiliated Hospital of Nanjing Medical University is a leading medical institution dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital is committed to implementing rigorous scientific methodologies to evaluate new therapies and treatment approaches. With a multidisciplinary team of experienced healthcare professionals and researchers, the hospital fosters a collaborative environment aimed at enhancing patient outcomes and contributing to the global medical community. Its strategic focus on translational medicine ensures that groundbreaking discoveries are efficiently translated into practical applications for patient care.

Locations

Nanjing, Jiangsu, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0