Mitoxantrone for Venetoclax Resistant Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Colorado, Denver
About this trial
This is an open label, phase 1 study for AML subjects with relapsed or refractory disease or subjects in morphologic remission with MRD+ after first line therapy with venetoclax+HMA. A preliminary dose-finding cohort will be followed by 3 expansion cohorts.
Eligibility criteria
Qualifiers
Subject must have confirmation of non-APL AML by WHO criteria and have been treated with first-line venetoclax/HMA (azacitidine or decitabine).
Subject must have relapsed disease per IWG criteria or disease refractory to first line venetoclax/HMA defined by less than a PR response after ≥ 1 complete cycle of venetoclax/HMA.
Subject must have either measurable residual disease (MRD+), as measured by FDA-approved flow cytometric test performed by Hematologics (cohort 3 and 4) or relapsed/refractory disease (cohort 1 and 2).
Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 2.
Disqualifiers
Subject has known active CNS involvement from AML.
Significant active cardiac disease within the previous 6 months including: New York Heart Association heart failure > class 2, unstable angina, or myocardial infarction.
Renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia.
Subject has a malabsorption syndrome or other condition that precludes enteral route of administration. This includes history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease (e.g.
Trial design
Treatments tested in this trial
- Venetoclax
- Azacitidine
- Mitoxantrone
Treatment groups
30 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of Colorado, Denver
Lead sponsor
The Leukemia and Lymphoma Society
Collaborator
Source ClinicalTrials.gov