Actively Recruiting
Venetoclax Combined with Intensive Therapy for Acute Myeloid Leukemia Patients with Lower Early Peripheral Blast Clearance Rate After Standard Induction Therapy
Led by Affiliated Hospital of Nantong University · Updated on 2024-11-12
83
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This single-center prospective cohort study aims to evaluate the efficacy and safety of Intensifying treatment with Venetoclax along with intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia (AML) except acute promyelocytic leukemia (non-APL) and exhibiting lower early peripheral blast clearance rate (EPBCR) after standard Intensive Induction therapy (3+7 regimen).
CONDITIONS
Official Title
Venetoclax Combined with Intensive Therapy for Acute Myeloid Leukemia Patients with Lower Early Peripheral Blast Clearance Rate After Standard Induction Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed AML, except for the APL subtype, according to the 2022 World Health Organization classification (WHO 2022 criteria)
- Age 18 years and 70 years
- Eligible for intensive chemotherapy
- No prior chemotherapy for AML except hydroxyurea for up to 14 days during the diagnostic screening phase for leukocytosis control
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
- Adequate kidney function: serum creatinine up to 2.0 times upper limit of normal and creatinine clearance over 30 mL/min
- Adequate liver and heart function: total bilirubin up to 1.5 times upper limit of normal unless due to Gilbert's disease or leukemia involvement; AST, ALT, and ALP up to 2.5 times upper limit of normal unless due to leukemia involvement; myocardial enzyme less than 2.0 times upper limit of normal; normal left ventricular ejection fraction by echocardiogram
- Signed informed consent form
- Female participants must be non-reproductive or have a negative pregnancy test at study entry
You will not qualify if you...
- AML with BCR-ABL1 or myeloid blast crisis of chronic myeloid leukemia (CML)
- Prior treatment for AML with chemotherapy, hypomethylating agents, or venetoclax
- Ineligible for intensive induction chemotherapy due to age over 70 or fitness criteria including ECOG performance status 2-3, heart failure requiring treatment or ejection fraction 50% or less, chronic stable angina, or lung function deficits
- History of myelodysplastic syndrome (MDS), myeloproliferative neoplasm (MPN), or MDS/MPN
- Other active malignant tumors except certain cured or controlled cancers
- Pregnant or breastfeeding women
- Active heart disease including uncontrolled angina, recent heart attack, arrhythmia needing medication, or symptomatic heart failure above NYHA grade 2
- Active uncontrolled systemic infections
- Active viral infections of HIV, hepatitis B or C not controlled by treatment
- Evidence of central nervous system leukemia before treatment
- Epilepsy requiring drug treatment, dementia, or mental states preventing study compliance
- Conditions preventing oral drug intake or absorption
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Affiliated hospital of Nantong University
Nantong, Jiangsu, China, 226001
Actively Recruiting
Research Team
Y
Yingxin Sun, Dr
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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