Actively Recruiting
Venetoclax-Decitabine in Untreated Elderly/Unfit AML
Led by The Second Hospital of Hebei Medical University · Updated on 2025-08-12
39
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
Sponsors
T
The Second Hospital of Hebei Medical University
Lead Sponsor
H
Handan First Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Acute myeloid leukemia (AML) is a highly fatal malignancy in China, with particularly poor outcomes in elderly patients. Low-intensity regimens yield low remission rates, and median overall survival (OS) typically remains under 6-9 months. Venetoclax (VEN) combined with hypomethylating agents (azacitidine or decitabine（DEC）) has emerged as a first-line therapy for these patients, significantly improving response rates and survival. However, challenges persist, including suboptimal complete remission (CR) rates, low Measurable Residual Disease（MRD） negativity, and tolerability issues with prolonged use. Recent studies suggest that a 3-day decitabine regimen combined with VEN may enhance efficacy and tolerability. Building on prior evidence and our institutional experience, we propose this study to evaluate an optimized dosing strategy of VEN plus decitabine in treatment-naïve elderly or chemotherapy-ineligible AML patients, aiming to further improve clinical outcomes.
CONDITIONS
Official Title
Venetoclax-Decitabine in Untreated Elderly/Unfit AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with acute myeloid leukemia (AML) according to WHO 2022 criteria, excluding acute promyelocytic leukemia and certain genetic subtypes
- AML not otherwise specified excluding acute panmyelosis with myelofibrosis and myeloid sarcoma
- Age 65 years or older and unwilling to receive intensive chemotherapy, or age over 18 years and ineligible for standard-dose chemotherapy due to health conditions
- No prior AML therapy except hydroxyurea or low-dose cytarabine under 1.0 g/day
- ECOG performance status of 3 or less
- Liver enzymes AST/ALT/ALP less than or equal to 3 times upper limit of normal (5 times if due to leukemia), total bilirubin less than or equal to 2 times upper limit
- Cardiac enzymes less than 2 times upper limit of normal
- Serum creatinine clearance 30 mL/min or higher
- Negative pregnancy test within 72 hours before treatment for women of childbearing potential and agreement to use effective contraception during and for 3 years after treatment
- Life expectancy of 2 months or more
- Signed informed consent by patient or legal guardian
You will not qualify if you...
- AML with BCR::ABL1 fusion or chronic myeloid leukemia in blast crisis
- Previously treated AML patients who have received induction chemotherapy
- Secondary AML including therapy-related AML or AML with prior myelodysplastic syndrome or myeloproliferative neoplasm
- Concurrent blood disorders like hemophilia or myelofibrosis unless confirmed non-MDS/MPN
- Pregnant or lactating women
- Allergy to study drugs
- Use of strong or moderate CYP3A4 inducers within 3 days before treatment
- Active cancers in other organs requiring treatment
- Severe liver or kidney dysfunction beyond inclusion limits
- Active heart disease such as recent heart attack, symptomatic arrhythmia, or uncontrolled heart failure
- Active infections including untreated tuberculosis, pulmonary aspergillosis, HIV, active hepatitis B or C
- Leukemia involving the central nervous system at baseline
- History of epilepsy requiring medication, dementia, or psychiatric disorders affecting study compliance
- Conditions impairing oral drug absorption
- Other investigator-determined reasons for ineligibility
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Second Hospital of Hebei Medical University
Hebei, China
Actively Recruiting
Research Team
L
LING XI GUO
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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