Minneapolis, MNNCT07008638Now EnrollingIRB Ready

Acute Myeloid Leukemia Clinical Trial in Minneapolis, MN

Access cutting-edge acute myeloid leukemia treatment through this clinical trial at a research site in Minneapolis. Study-provided care at no cost to qualified participants.

Sponsored by Masonic Cancer Center, University of Minnesota

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Expert Care in Minneapolis

Access acute myeloid leukemia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related acute myeloid leukemia treatment provided free

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Check if you qualify for this acute myeloid leukemia clinical trial in Minneapolis, MN

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Why Participate?

  • No-Cost Study Care

  • Local to Minneapolis

    Convenient for MN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Minneapolis site if eligible
  4. 4Begin participation

About This Acute Myeloid Leukemia Study in Minneapolis

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.

Sponsor: Masonic Cancer Center, University of Minnesota

Who Can Participate

Inclusion Criteria

Adult (age ≥ 18 years at time of consent)
Have not received any systemic chemotherapy for the treatment of AML. Use of hydroxyurea and leukapheresis to control excess peripheral blasts is permissible. WBC \< 25,000 to initiate bortezomib, must reach this threshold by day 7 of CPX-351.
Karnofsky performance status (KPS) ≥ 70
Adequate renal, hepatic and cardiac function defined as
Renal: An estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
Hepatic: AST and ALT ≤3 x ULN, ALP ≤2.5 x ULN, and total bilirubin ≤1.5 x ULN. (exception for Gilbert's syndrome or leukemic infiltration of liver)
Cardiac: New York Heart Association (NYHA) Class I or II, left ventricular ejection fraction \> 50% by echocardiogram, MUGA or cardiac MRI
Sexually active couples of childbearing potential must agree to use effective contraception or abstinence during treatment and for at least 7 months after the final dose of study drug
Provides voluntary written consent before the performance of any study related activities not part of standard of care.

Exclusion Criteria

Received systemic chemotherapy for the treatment of AML
Bi-phenotypic acute leukemia or mixed lineage leukemia, acute promyelocytic leukemia
Active central nervous system malignancy or symptoms of CNS involvement
Symptomatic extramedullary disease
Known history of uncontrolled HIV or active hepatitis B or active hepatitis C infection
Has any of the following cardiac abnormalities
Symptomatic congestive heart failure
Myocardial infarction less than or equal to 6 months prior to enrollment
Unstable angina pectoris
Serious uncontrolled cardiac arrhythmia
Concomitant malignancies or previous malignancies with less than a 1-year disease free interval at the time of signing consent. Potential participants with adequately resected basal or squamous cell carcinoma of the skin, or adequately resected carcinoma in situ (e.g., cervix) may enroll irrespective of the time of diagnosis
Participants for whom administration of CPX-351 would exceed their lifetime cumulative daunorubicin exposure limit of 550 mg/m2 (or 400 mg/m2 in patients with prior chest radiation) or equivalent anthracycline dose.
Pregnant or breastfeeding, or planning pregnancy within 3 months after the treatment completion

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Minneapolis?

Yes, this clinical trial (NCT07008638) has an active research site in Minneapolis, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Myeloid Leukemia Treatment Options in Minneapolis, MN

If you're searching for acute myeloid leukemia treatment options in Minneapolis, MN, this clinical trial (NCT07008638) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Minneapolis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced acute myeloid leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute myeloid leukemia clinical trials near you to find additional studies recruiting in your area.

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