Trial Summary
What is the purpose of this trial?This trial is testing a combination of two drugs, CPX-351 and Glasdegib, in patients with a specific type of leukemia that is hard to treat. CPX-351 kills cancer cells, and Glasdegib stops them from growing. The goal is to see if this combination is effective for these patients.
Eligibility Criteria
Adults over 18 with newly diagnosed, untreated Acute Myelogenous Leukemia (AML) that's related to prior therapy or myelodysplastic syndromes. Participants must have good heart function and organ health, not be pregnant or breastfeeding, agree to use birth control, and cannot have certain heart conditions, uncontrolled infections, other active cancers requiring treatment, or a history of severe medical disorders.Inclusion Criteria
I am 18 years old or older.
I can take care of myself and am up and about more than half of my waking hours.
I am a woman who could potentially become pregnant.
+14 more
Exclusion Criteria
Baseline QT corrected interval based on Fridericia's formula (QTcF) interval > 450 ms
I have had a heart attack or severe heart issue in the last year.
I am HIV positive.
+15 more
Participant Groups
The trial is testing the effectiveness of combining two drugs: CPX-351 (a chemotherapy drug) and Glasdegib (a targeted therapy), in treating AML. It's an open-label study where all participants receive the same treatment without a comparison group.
1Treatment groups
Experimental Treatment
Group I: CPX-351 and GlasdegibExperimental Treatment2 Interventions
In Induction, subjects receive 44mg/m2/100mg/m2 IV on days 1, 3 and 5 and Glasdegib 100mg PO daily on days 6 to 28.
If re-induction is needed: Subjects receive 44mg/m2/100mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
In consolidation: Subjects receive 29mg/m2/65mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
If maintenance is required, Subjects receive Glasdegib 100mg PO daily for up to one year
CPX-351 is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as VYXEOS for:
- Newly-diagnosed therapy-related acute myeloid leukemia (t-AML)
- AML with myelodysplasia-related changes (AML-MRC)
🇪🇺 Approved in European Union as VYXEOS for:
- Newly-diagnosed therapy-related acute myeloid leukemia (t-AML)
- AML with myelodysplasia-related changes (AML-MRC)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, Los AngelesLos Angeles, CA
Moores Cancer Center, Unversity of California, San DiegoLa Jolla, CA
University of California, San FranciscoSan Francisco, CA
Chao Family Comprehensive Cancer Center, University of California, IrvineOrange, CA
More Trial Locations
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Who Is Running the Clinical Trial?
University of California, IrvineLead Sponsor
PfizerIndustry Sponsor
Jazz PharmaceuticalsIndustry Sponsor