Venetoclax to Augment Epigenetic Modification and Chemotherapy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1-25
SponsorMedical College of Wisconsin
About this trial
The investigator is testing the addition of venetoclax to 5-azacitidine and vorinostat followed by standard chemotherapy to enhance treatment response in AML patients.
Eligibility criteria
Qualifiers
Diagnosis
Patients with AML must have measurable disease (≥M1 marrow) in the bone marrow.
1st or greater relapse, OR
Failed to go into remission after 1st or greater relapse, OR
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Venetoclax
- Azacitadine
- Vorinostat
- Cytarabine
- Fludarabine
- Filgrastim
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov