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

Completed · Phase 1

Conditions studied: Myeloid Malignancy

In brief

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 facts

Study ID

NCT04214860

Run by

Aprea Therapeutics

People needed

51

Starts

2019-12-13

Expected to finish

2022-01-14

Last updated by the study team

2025-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent and ability to comply with protocol requirements.
• Documented diagnosis of AML according to World Health Organization WHO) classification
• Adequate organ function as defined by the following laboratory values:
• Creatinine clearance > 30 mL/min
• Total serum bilirubin < 1.5 × ULN
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 × ULN
• Age ≥18 years
• At least one TP53 mutation
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• Projected life expectancy of ≥ 12 weeks.
• Negative serum or urine pregnancy test
• Females of childbearing potential and males with female partners of childbearing potential must be willing to use an effective form of contraception

You may not qualify if…

• Prior treatment for TP53-mutant AML (*dependent upon treatment arm assigned).
• Known history of HIV or active hepatitis B or active hepatitis C infection.
• Any of the following cardiac abnormalities:
• Myocardial infarction within six months prior to registration;
• New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction (LVEF) < 40%;
• A history of familial long QT syndrome;
• Symptomatic atrial or ventricular arrhythmias
• QTcF ≥ 470 msec, unless due to underlying bundle branch block and/or pacemaker and with approval of the medical monitor.
• Concomitant malignancies for which patients are receiving active therapy
• Known active CNS involvement from AML.
• Malabsorption syndrome
• Pregnancy or lactation.
• Active uncontrolled systemic infection (viral, bacterial or fungal).

Where it is running

• Yale Cancer Center — New Haven, Connecticut, United States
• H. Lee Moffitt CC — Tampa, Florida, United States
• Northwestern Medicine — Chicago, Illinois, United States
• University of Chicago Medicine — Chicago, Illinois, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Weill Cornell Cancer Center — New York, New York, United States
• Memorial Sloan Kettering CC — New York, New York, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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