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

NCT04214860 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-03-17

Study results available
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Summary

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.

Conditions

  • Myeloid Malignancy

Interventions

DRUG

APR-246

APR-246 4.5 g/day

DRUG

Venetoclax

Venetoclax 400 mg once daily

DRUG

Azacitidine

Subcutaneous injection, or intravenous infusion

Sponsors & Collaborators

  • Aprea Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-13
Primary Completion
2022-01-14
Completion
2022-01-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04214860 on ClinicalTrials.gov