Actively Recruiting
Clinical Study Protocol of IAV-induced Remission Followed by Consolidation Therapy With MDCyta+Ven in ND-AML
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-01-31
54
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
H
Huai'an First People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study Protocol of IAV-induced Remission Followed by Consolidation Therapy With MDCyta+Ven in ND-AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed primary AML patients based on 2022 WHO classification.
- Age between 18 and 60 years old.
- ECOG performance status of 0 to 2.
- Cardiac ultrasound showing left ventricular ejection fraction (LVEF) of 45% or higher.
- Creatinine clearance of 50 mL/min or higher.
- Liver function with AST and ALT levels 2.5 times or less the upper limit of normal and total bilirubin 1.5 times or less the upper limit of normal, unless due to leukemia.
- Signed informed consent form.
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL).
- Relapsed or refractory AML.
- AML with known central nervous system involvement.
- Known HIV infection.
- Positive hepatitis B or C virus infection, except non-active carriers or low viral load after treatment.
- Use of strong or moderate CYP3A inducers or inhibitors within 7 days before treatment.
- New York Heart Association (NYHA) heart function classification above Grade 2.
- Chronic respiratory disease requiring continuous oxygen therapy.
- Inability to take oral medications or malabsorption syndrome.
- Uncontrolled systemic infection.
- Previous venetoclax treatment or participation in other investigational drug studies.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
M
Ming Hong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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