Actively Recruiting
Phase I/II Clinical Trial of Proteasome Inhibitor in Combination With CPX-351 for the Treatment of Newly-Diagnosed TP53-mutated Acute Myeloid Leukemia (AML)
Led by Masonic Cancer Center, University of Minnesota · Updated on 2025-07-09
32
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I/II study evaluating safety and efficacy of proteasome inhibitor (bortezomib) in combination with CPX-351 (liposomal daunorubicin and cytarabine) for the treatment of newly-diagnosed TP53-mutated acute myeloid leukemia (TP53m AML). The primary endpoint of the study is to define safety/tolerability (phase I) and preliminary efficacy profile (phase II) of the treatment. The secondary endpoints of interest are complete remission (CR) rate, detectable minimal residual disease (MRD) status, overall response rate (ORR), rate of allogeneic hematopoietic cell transplantation (allo-HCT), treatment-related mortality (TRM), overall survival (OS), achievement of complete remission anytime in 1 year, and disease-free survival (DFS) at 1 year and 2 years. All the patient outcomes assessments will be performed as part of standard-of-care AML management. The hypothesis is the combination of bortezomib and CPX-351 will have an acceptable safety profile in this patient population based on the data from previous studies. The treatment will attenuate Nuclear Factor kB pathway activation in these cells and eradicate TP53m leukemia stem cells (LSC) leading to increased response rate and survival in these patients.
CONDITIONS
Official Title
Phase I/II Clinical Trial of Proteasome Inhibitor in Combination With CPX-351 for the Treatment of Newly-Diagnosed TP53-mutated Acute Myeloid Leukemia (AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (age 218 years at time of consent
- Have not received any systemic chemotherapy for AML treatment (hydroxyurea and leukapheresis allowed to control blasts)
- White blood cell count less than 25,000 to start bortezomib; must reach this by day 7 of CPX-351
- Karnofsky performance status 70 or higher
- Adequate kidney, liver, and heart function as defined by specific laboratory and clinical measures
- Sexually active participants of childbearing potential must agree to use effective contraception or abstinence during treatment and for 7 months after last dose
- Voluntary written consent provided before any study procedures not part of standard care
You will not qualify if you...
- Received systemic chemotherapy for AML treatment
- Bi-phenotypic acute leukemia, mixed lineage leukemia, or acute promyelocytic leukemia
- Active central nervous system cancer or symptoms of CNS involvement
- Symptomatic disease outside the bone marrow
- Uncontrolled HIV or active hepatitis B or C infection
- Certain serious heart conditions including congestive heart failure, recent heart attack (within 6 months), unstable angina, or uncontrolled arrhythmia
- Other cancers with less than 1-year disease-free interval, except certain skin and cervical cancers properly treated
- Lifetime anthracycline exposure exceeding set limits
- Pregnant, breastfeeding, or planning pregnancy within 3 months after treatment completion
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Trial Site Locations
Total: 1 location
1
Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
J
Joseph Norton, DO
CONTACT
Z
Zohar Sachs, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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