Actively Recruiting
Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML
Led by OHSU Knight Cancer Institute · Updated on 2026-04-13
40
Participants Needed
2
Research Sites
173 weeks
Total Duration
On this page
Sponsors
O
OHSU Knight Cancer Institute
Lead Sponsor
O
Oregon Health and Science University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests how well venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax works in treating patients with newly diagnosed monocytic acute myeloid leukemia (AML) and active signaling mutated AML. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as cladribine, cytarabine and azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax may kill more cancer cells in patients with newly diagnosed monocytic AML and active signaling mutated AML.
CONDITIONS
Official Title
Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the study and provide informed consent or have a legal representative do so
- Signed consent for the related biorepository before any study procedures
- Newly diagnosed, confirmed monocytic AML or active signaling mutated AML with specified mutations
- Ineligible for or unwilling to undergo intensive chemotherapy induction therapy
- For patients 75 years or older: creatinine clearance ≥ 30 ml/min, total bilirubin ≤ 1.5 times upper limit of normal, liver enzymes ≤ 3 times upper limit of normal, and ECOG performance status 0 to 2
- Willing and able to provide bone marrow samples for research
- Willing and able to accept supportive care for blood-related side effects and infections
- Willing to follow study schedule, bio sample collections, and lifestyle restrictions during treatment
- Negative pregnancy test within 24 hours before treatment start for persons who can become pregnant
- Willingness to use approved contraception during and after treatment as specified
You will not qualify if you...
- Symptomatic central nervous system involvement with AML
- Prior AML treatment except limited cytoreduction therapies
- Another active cancer within 5 years before treatment start
- Use of investigational therapy within 28 days or 5 half-lives before treatment
- Recent major surgery within 28 days or stem cell transplant within 100 days without active graft versus host disease treatment
- Allergy to study drugs or any components
- Prior treatment targeting BCL-2 within 5 years
- Conditions affecting ability to take oral drugs properly
- Use of certain interacting drugs shortly before treatment
- Uncontrolled infection or unstable medical conditions affecting heart, lungs, or mental health
- Active hepatitis B or C infection unless evaluated case-by-case
- HIV infection under therapy that may interfere with study drugs
- Pregnancy or unwillingness to stop breastfeeding
- Any illness or situation that may prevent following study requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
2
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
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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