Actively Recruiting
Venetoclax to Augment Epigenetic Modification and Chemotherapy
Led by Medical College of Wisconsin · Updated on 2026-01-12
40
Participants Needed
1
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The investigator is testing the addition of venetoclax to 5-azacitidine and vorinostat followed by standard chemotherapy to enhance treatment response in AML patients.
CONDITIONS
Official Title
Venetoclax to Augment Epigenetic Modification and Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 1 to 25 years with measurable AML disease in bone marrow
- Patients with 1st or greater relapse, refractory disease, or treatment-related AML
- Patients with CNS or other extramedullary disease without cranial irradiation during therapy
- Patients with immunophenotypic AML evolving from ALL or acute leukemia NOS with relapsed/refractory disease
- Patients with Down syndrome
- Karnofsky performance status >50% for patients >16 years or Lansky >50% for patients 6 years
- Fully recovered from prior myelosuppressive chemotherapy, immunotherapy, or radiotherapy
- At least 7 days since last cytotoxic therapy (except intrathecal chemotherapy)
- At least 90 days post hematopoietic stem cell transplant without active GVHD or therapy
- At least 7 days since growth factor therapy (14 days if pegfilgrastim)
- At least 7 days since last biologic agent dose
- At least 3 half-lives elapsed since last monoclonal antibody dose
- At least 42 days since completion of any immunotherapy
- Able to tolerate antifungal prophylaxis during treatment and neutrophil recovery
- Dose adjustments for patients taking CYP3A4 or P-glycoprotein inhibitors
- Adequate renal function with creatinine clearance or normal serum creatinine
- Adequate liver function or approved waiver for liver involvement
- Adequate cardiac function with shortening fraction 6 27% or ejection fraction 6 50%
- Negative pregnancy test for females of childbearing potential
- Agreement to avoid breastfeeding during study
- Use of effective contraception during and for 6 months after study
- Ability to understand study and provide informed consent or assent
You will not qualify if you...
- Known allergy to any study drug
- Ongoing systemic infection with persistent symptoms despite treatment
- Positive fungal culture within 30 days or evidence of disseminated fungal disease
- Planned non-protocol chemotherapy, radiation, or immunotherapy during study
- Significant concurrent disease, psychiatric disorder, or social issues affecting safety or compliance
- DNA fragility syndromes such as Fanconi anemia or Bloom syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
A
Amberley Kemic, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here