Actively Recruiting
Venetoclax Plus Hypomethylating Agents and Subcutaneous Cytarabine for CEBPA-Mutated AML
Led by The First Affiliated Hospital of Soochow University · Updated on 2026-03-05
29
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if a treatment combination-venetoclax plus hypomethylating agents (like azacitidine or decitabine) and low-dose cytarabine-works to treat adults with newly diagnosed CEBPA-mutated acute myeloid leukemia (AML) who can't tolerate intensive chemotherapy. It will also check how safe this treatment combination is and explore how the disease might change if it comes back. The main questions it aims to answer are: 1. How well does this treatment combination prevent the disease from coming back (relapse-free survival)? 2. What percentage of participants achieve a good response (complete remission or complete remission with incomplete blood cell recovery) after 2 treatment cycles? 3. What percentage of participants have no detectable remaining leukemia cells (measurable residual disease, MRD) after treatment? What side effects do participants have, and how serious are these side effects? Participants will: 1. First, go through a 2-cycle "induction phase": Take venetoclax by mouth (100mg on day 1, 200mg on day 2, 400mg from day 3 to day 28), get hypomethylating agents (azacitidine injected under the skin or decitabine injected into a vein), and low-dose cytarabine (injected under the skin) as planned. 2. If they respond well to induction treatment, move to a "consolidation phase" and receive at least 4 more cycles of the same treatment combination. 3. Have regular check-ups during treatment (like blood tests, bone marrow tests, and heart checks) to monitor treatment response and side effects. 4. Be followed up for 2 years after treatment ends to check if the disease comes back and their overall health.
CONDITIONS
Official Title
Venetoclax Plus Hypomethylating Agents and Subcutaneous Cytarabine for CEBPA-Mutated AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years, male or female who is not pregnant or lactating
- Newly diagnosed acute myeloid leukemia (AML) with CEBPA mutation
- ECOG performance status of Grade 3 or lower
- Able to understand the study and willing to sign informed consent
- Judged as "unfit" for intensive chemotherapy based on criteria such as age over 75, severe heart, lung, kidney, or liver disease, active infection not responding to treatment, cognitive impairment, poor performance status, or other comorbidities
You will not qualify if you...
- Pregnant or lactating women
- Previous chemotherapy or targeted therapy for leukemia, except hydroxyurea or leukapheresis
- Unable to complete all required study visits or procedures
- Other conditions judged by the investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
S
Suning Chen
CONTACT
W
Wenzhi Cai
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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