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)

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT07008638
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bortezomib — DRUG
    Bortezomib at assigned study dose in mg/m2 will be given subcutaneously on days 1, 4, 8, and 11
  • CPX-351 — DRUG
    CPX-351 given intravenously on day 1, 3, and 5

Study Details

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.

Key Dates

Start date
Jul 7, 2025
Status verified
Jul 2025
Primary completion
Dec 30, 2027
Completion
Jan 27, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Dose Level -1
    Bortezomib 0.7mg/m2 in combination with CPX-351
  • Experimental: Phase 1: Dose Level 2
    Bortezomib 1mg/m2 in combination with CPX-351
  • Experimental: Phase 1: Dose Level 3
    Bortezomib 1.3 mg/m2 in combination with CPX-351
  • Experimental: Phase 1: Dose Level 4
    Bortezomib 1.5 mg/m2 in combination with CPX-351
  • Experimental: Phase 2
    Maximum tolerated dose of Bortezomib in combination with CPX-351

Primary Outcome Measure

Percentage of Participants with Complete Response [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer CenterMinneapolisMinnesota55455
Joseph Norton, DO
[email protected]
612-626-3107

Find similar trials in Minneapolis, MN

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Masonic Cancer Center· Minneapolis, MN

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