Actively Recruiting
Mitoxantrone for Venetoclax Resistant Acute Myeloid Leukemia
Led by University of Colorado, Denver · Updated on 2026-01-15
30
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
T
The Leukemia and Lymphoma Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mitoxantrone for Venetoclax Resistant Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of non-APL AML by WHO criteria and prior treatment with first-line venetoclax plus hypomethylating agent (azacitidine or decitabine)
- Relapsed disease by IWG criteria or refractory disease with less than partial response after at least one complete cycle of venetoclax plus hypomethylating agent
- Presence of measurable residual disease (MRD+) for cohorts 3 and 4, or relapsed/refractory disease for cohorts 1 and 2
- Eastern Cooperative Oncology Group (ECOG) Performance status of 2 or less
- Adequate kidney function with creatinine clearance of 60 mL/min or higher, calculated by CKD-EPI formula
- Adequate heart function with left ventricular ejection fraction (LVEF) greater than 50%, assessed by MUGA or echocardiogram within 1 month before study start
- Adequate liver function with AST and ALT no more than 3 times the upper limit of normal, and bilirubin no more than 1.5 times the upper limit unless due to Gilbert's syndrome or leukemic organ involvement
- Non-sterile males must use contraception before and for 90 days after study drug administration unless surgically sterile or partner is permanently sterile or postmenopausal
- Female participants must be postmenopausal, permanently surgically sterile, or if of childbearing potential, use contraception during treatment and for 6 months after last dose
- Voluntarily sign informed consent approved by Institutional Review Board (IRB) before starting any study procedures
You will not qualify if you...
- Known active central nervous system (CNS) involvement from AML
- Significant active cardiac disease within 6 months such as heart failure above class 2, unstable angina, or recent myocardial infarction
- Other serious renal, neurological, psychiatric, endocrine, metabolic, immune, liver, cardiovascular, or bleeding disorders unrelated to leukemia
- Malabsorption syndromes or gastrointestinal conditions preventing oral drug absorption, including inflammatory bowel disease, celiac disease, or prior bowel surgery
- Uncontrolled systemic infections requiring therapy with ongoing symptoms despite treatment
- History of other cancers except adequately treated in situ breast or cervix carcinoma, basal or localized squamous cell skin carcinoma, prostate cancer controlled by hormonal therapy, or fully treated malignancies with curative intent
- White blood cell count greater than 25 x 10^9/L (hydroxyurea or apheresis allowed in cohort 3)
- Pregnant or breastfeeding women
- Known or suspected allergy to azacitidine or mannitol
- Prior exposure to anthracycline or anthracenedione drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
D
Derek Schatz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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