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Venetoclax, Azacitadine, and Vorinostat for Relapsed or Refractory AML

This study is looking at a new way to treat acute myeloid leukemia (AML) that has come back (relapsed) or hasn't responded to previous treatments (refractory). Researchers are testing if adding venetoclax to a combination of azacitadine and vorinostat, followed by standard chemotherapy (cytarabine and fludarabine), can improve treatment response. The study is open to children, adolescents, and young adults aged 1 to 25 years old with AML that meets specific criteria for relapse or not achieving remission. The main goal is to see if venetoclax causes any dose-limiting side effects. The current enrollment status is unclear, and the study plans to include 40 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 40 participants, including those with and without Down syndrome.
What's involved
Participants will receive two cycles of therapy, each lasting 35 days. The specific schedule for drug administration is detailed in the intervention section.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring venetoclax dose-limiting toxicity is at 42 months.

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NCT05317403

Venetoclax to Augment Epigenetic Modification and Chemotherapy

Recruiting
PHASE1Ages 1–25InterventionalTreatment
Medical College of Wisconsin
~40 participants
Updated 2026-01-12 on ClinicalTrials.gov
What's tested:VenetoclaxAzacitadineVorinostatCytarabineFludarabineFilgrastim

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Venetoclax Dose-Limiting Toxicity
Measured over 42 months

Conditions

Acute Myeloid Leukemia, in Relapse
Acute Myeloid Leukemia Refractory

Explore related trials

Acute Myeloid Leukemia

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Michael Burke, MD · STUDY_CHAIR · Medical College of Wisconsin

Who to contact

Amberley Kemic, RN
[email protected]
414-266-2038
Email the study team

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Eligibility criteria

Inclusion

Diagnosis
1st or greater relapse, OR
Failed to go into remission after 1st or greater relapse, OR
Failed to go into remission from original diagnosis after 2 or more induction attempts 2. Patients may have CNS or other sites of extramedullary disease. No cranial irradiation is allowed during the protocol therapy. 3. Patients with treatment related AML (tAML) are eligible. A relapse of tAML is not necessary to enroll on this study thus newly diagnosed tAML are eligible. 4. Patients with immunophenotypic AML evolving as lineage switch from ALL or acute leukemia NOS, may be eligible if they have relapsed/refractory disease 5. Patients with Down syndrome are eligible
Performance Level- Karnofsky \> 50% for patients \> 16 years of age and Lansky \> 50% for patients ≤ 16 years of age. (See Appendix II for Performance Scales)
Prior Therapy- Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
Patients taking strong CYP3A4 inhibitors should have their venetoclax dose reduced by 75%
Patients taking moderate CYP3A4 inhibitors should have their venetoclax dose reduced by 50%
Inhibitors of P-glycoprotein (P-gp): Patients taking p-glycoprotein inhibitors should have their venetoclax doses reduced by 50%.
Renal and hepatic function- Patients must have adequate renal and hepatic functions as indicated by the following laboratory values:
Adequate Cardiac Function Defined as: Shortening fraction of ≥ 27% OR ejection fraction of ≥ 50%.
Reproductive Function
Informed Consent- Patients and/or their parents or legal guardians must be capable of understanding the investigational nature, potential risks, and benefits of the study. All patients and/or their parents or legal guardians must sign a written informed consent. Age-appropriate assent will be obtained per institutional guidelines. To allow non-English speaking patients to participate in this study, bilingual health services will be provided in the appropriate language when feasible.
Protocol Approval- All institutional, FDA, and OHRP requirements for human studies must be met.

Exclusion

Patients will be excluded if they have a systemic fungal, bacterial, viral, or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The patient needs to be off pressors and have negative blood cultures for 48 hours.
Patients will be excluded if they have had any positive fungal culture within 30 days prior to enrollment or evidence of disseminated fungal disease.
Patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period.
Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder, or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with consent, study participation, follow up, or interpretation of study results.
Patients with DNA fragility syndromes (such as Fanconi anemia, Bloom syndrome) are excluded.

What this trial measures

  • Venetoclax Dose-Limiting Toxicity42 months

    The primary endpoint, for dose escalation of venetoclax, is the occurrence of a dose-limiting toxicity (DLT) observed during the first course of therapy.