APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Aprea Therapeutics
Study ID
NCT04214860
Phase
PHASE1
Status
Completed

Conditions

  • Myeloid Malignancy

Eligibility Criteria

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

Interventions

  • APR-246 — DRUG
    APR-246 4.5 g/day
  • Venetoclax — DRUG
    Venetoclax 400 mg once daily
  • Azacitidine — DRUG
    Subcutaneous injection, or intravenous infusion

Study Details

This clinical trial is a Phase I, open-label, dose-finding and cohort expansion study to determine the safety and preliminary efficacy of APR-246 in combination with venetoclax and azacitidine in patients with myeloid malignancies.

Key Dates

Start date
Dec 13, 2019
Status verified
Mar 2025
Primary completion
Jan 14, 2022
Completion
Jan 14, 2022

Study Design

Enrollment
51 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: APR-246
    APR-246 4.5 g/day

Primary Outcome Measure

To Evaluate the Tolerabililty and the Incidence of Treatment-Emergent Adverse Events of Administration of APR 246 in Combination With Venetoclax and Azacitidine in Patients With TP53 Mutant Myeloid Malignancies. [ Time Frame: From baseline until event occures, i.e. through study completion, an average of 1 year ]

Locations (8)

FacilityCityStateZIPSite coordinators
Yale Cancer CenterNew HavenConnecticut06511-
H. Lee Moffitt CCTampaFlorida33612-
Northwestern MedicineChicagoIllinois60611-
University of Chicago MedicineChicagoIllinois60637-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Memorial Sloan Kettering CCNew YorkNew York10065-
Weill Cornell Cancer CenterNew YorkNew York10021-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in New Haven, CT

By research site
Yale Cancer Center· New Haven, CTH. Lee Moffitt CC· Tampa, FLNorthwestern Medicine· Chicago, ILUniversity of Chicago Medicine· Chicago, ILDana Farber Cancer Institute· Boston, MAMemorial Sloan Kettering CC· New York, NY

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